User login
Over half of targetable NSCLC patients miss out on correct tx
because of gaps in clinical practice all along the cancer care spectrum, reveals a new analysis of data from U.S. practices.
For some of these patients, it could mean missing the chance for long-term survival or even cure.
One lung cancer patient, Janet Freeman-Daily, recently tweeted that she entered a targeted therapy clinical trial 10 years ago and is still taking the same, now approved, oral drug, with “no evidence of disease.”
Patients who have lung cancer with mutations that can be targeted with drug therapies – but who do not receive them – are missing this opportunity.
The new study suggests that there are many such patients. The researchers analyzed data on more than 38,000 patients with actively managed advanced NSCLC. They found that about half did not receive biomarker test results for a variety of reasons. But even among the half who were successfully tested, 30% of these patients did not receive the appropriate targeted therapies.
Overall, around 64% of eligible patients with advanced NSCLC are not benefiting from the most appropriate therapies, the team concludes.
The research was published online in JCO Precision Oncology.
Gaps in clinical practice
The high rate of failure points to clinical practice gaps in “many areas” across the cancer care spectrum, lead author Daryl Pritchard, PhD, from the Personalized Medicine Coalition, Washington, told this news organization.
“There’s various steps along the way that affect clinicians, laboratories, payers, the health providers [and] even patients,” he said. He added that product manufacturers also “have a role.”
“So it’s not an individual group that’s causing the problem. It’s a systemic awareness and systemic need to improve the delivery process.”
Dr. Pritchard underlined that the “the main goal of this analysis is to put everybody on alert that we need to do something about it.
“We need to – and this is easy to say but hard to do – evolve health care from a traditional one-size-fits-all mentality to a value-based strategy where you’re saying we want the best treatments” for patients, he said.
This means developing optimized and standardized laboratory processes, as well as clinical guidelines that set out the standard of care and optimized and integrated clinical decision support.
“We need to work as a community to demonstrate the value of this care and improve education and awareness to providers and payers,” Dr. Pritchard said. “That will encourage value-based practice coverage and reimbursement policies, and then also incentivize utilization in validated cases.”
Julie R. Brahmer, MD, who directs the thoracic oncology program at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, who was not involved with the study, said she was not sure whether she would say she was “surprised or disheartened” by the findings.
The study was focused on advanced NSCLC patients treated in 2019. Dr. Brahmer wondered whether the COVID-19 pandemic “might actually have made things worse.”
It will be important to “drill down” into some of the reasons why 30% of patients for whom biomarker testing results were available did not receive the appropriate treatment, she said.
Aside from cost-related problems, one factor at play could be whether the patient saw an oncologist, she said, while another could be that they went “straight to hospice” and were “not healthy enough to be able to tolerate” their targeted therapy.
Greater use of liquid biopsies, which identify biomarkers in the blood, are one way to improve access to biomarker testing, she suggested. It would help if these liquid biopsies were “consistently paid for by the payer, particularly for patients with advanced disease,” she added. Currently, payers often want patients to first undergo a tissue biopsy, which involves lung aspiration and may not be possible for some patients.
“If a Medicare patient is in the hospital when they have their biopsy or surgery, and then they have to wait 14 days in order for mutation tests to be ordered, and then if you add another 2 weeks for that test to come back, or even longer … [These delays] are some of the reasons why patients didn’t end up receiving therapy,” she elaborated.
“Some of these patients just can’t last that long before starting treatment,” she said.
Sandip P. Patel, MD, an oncologist at the Precision Immunotherapy Clinic at the University of California, San Diego, in La Jolla, wondered whether the issue is lack of education among physicians or whether there are potential financial problems. “Is there a financial risk to patients, for example, that is not being captured?” he mused.
It could also be a question of urban vs. rural centers, language barriers in communicating to patients, or other social determinants of health, he added.
At his institution (UCSD), there are “multiple choices” of molecular tests, each with “little nuances that differ among the tests that folks sometimes will take a look at in term of picking the best.
“But the best test is the one that gets done, and here we’re seeing no testing at all” for many patients, he said.
“It’s really unfortunate because for a lot of these patients, not only are they not getting the latest therapy, but they’re often getting something else that’s expensive and toxic instead,” Dr. Patel said.
Referring to the relatively high proportion of patients who didn’t receive targeted therapy even after being tested, he said, “For me, this study leaves more questions and answers.
“We’ve seen a lot of work in this space, showing us the problem,” Dr. Patel said. “What I haven’t yet seen is a very discrete analysis of the cause of that problem upstream.”
Cornerstone of personalized medicine
In their article, Dr. Pritchard and colleagues note that more than 90 targeted therapies have been approved by the U.S. Food and Drug Administration for use in eligible cancer patients. An estimated 55% of recent oncology trials involved the use of biomarkers.
Predictive biomarker testing to identify patients who may benefit from targeted therapies “is a cornerstone of personalized medicine in cancer care, allowing for more rapid diagnosis while informing treatment decisions that could lead to better patient outcomes and systemic efficiencies,” they emphasize.
However, providers “face several challenges” when integrating biomarker testing and targeted therapeutics into cancer care, and the use of biomarker testing varies widely across tumor types, biomarkers, and practice settings.
For their study, the team examined the use of targeted therapy in advanced NSCLC using data from the Diaceutics Data Repository, which includes commercial and Medicare claims, as well as laboratory data.
They focused on 38,068 patients with actively managed advanced NSCLC. Of those patients, 50.80% were women, and 64.6% were aged 71 years or older. The vast majority (84.50%) were non-Hispanic White patients.
The team examined the impact of seven clinical practice gaps on the timeline from ordering a biopsy to delivering targeted treatment. They then normalized the results to a standard patient population of 1,000.
In 6.6% of cases, an initial tissue or liquid biopsy was never performed, meaning that 66 of the 1,000 patients could not progress toward targeted therapy.
Among those who underwent a biopsy, for 4.0%, there was insufficient tissue on the initial biopsy, while for a further 0.97%, there was insufficient tissue on re-biopsy. Moreover, 9.6% could not undergo biopsy testing because of a lack of tumor tissue. Consequently, a further 136 of the 944 remaining patients were lost.
For the third clinical practice gap, the tumor cell content was overestimated in 1.7% of patients. As a result, their biopsy specimen could not be tested because it did not meet the threshold requirements. This resulted in the loss of a further 14 patients.
Moreover, for a further 17.5% of patients, biomarker testing was not ordered at all, owing to cost concerns, a lack of access to testing, a lack of awareness of testing options, and low confidence in the results, among other reasons. An additional 0.6% began treatment before any testing was ordered; together, that accounted for 142 patients being lost.
Even among patients who underwent biomarker testing, 14.5% had uninformative or inconclusive results, and 3.9% had false-negative results, meaning that a further 118 patients were lost.
In another 4.0% of cases, the results of biomarker testing did not arrive within the treatment decision window, owing to delays in reporting the results, and so for these patients, treatment began without the results being taken into consideration. A further 21 patients were lost.
The final clinical practice gap was not choosing the appropriate targeted treatment on the basis of test results. The researchers found that of 27,186 patients who underwent biomarker testing and received a timely result, 29.2% were not given the corresponding therapy. This resulted in the loss of a further 147 of the original 1,000 patients.
Overall, the team calculated that 64.4% of patients newly diagnosed with advanced NSCLC “are not benefiting from precision oncology care options appropriate for their diseases and will likely have suboptimal outcomes.”
The research was supported in part by the Personalized Medicine Coalition, a nonprofit 501c3 organization dedicated to the advancement of personalized medicine. Dr. Pritchard is an employee of the Personalized Medicine Coalition. A coauthor has relationships with Thermo Fisher Scientific, AstraZeneca, Eli Lilly, Blueprint Medicines, and Oncocyte.
A version of this article first appeared on Medscape.com.
because of gaps in clinical practice all along the cancer care spectrum, reveals a new analysis of data from U.S. practices.
For some of these patients, it could mean missing the chance for long-term survival or even cure.
One lung cancer patient, Janet Freeman-Daily, recently tweeted that she entered a targeted therapy clinical trial 10 years ago and is still taking the same, now approved, oral drug, with “no evidence of disease.”
Patients who have lung cancer with mutations that can be targeted with drug therapies – but who do not receive them – are missing this opportunity.
The new study suggests that there are many such patients. The researchers analyzed data on more than 38,000 patients with actively managed advanced NSCLC. They found that about half did not receive biomarker test results for a variety of reasons. But even among the half who were successfully tested, 30% of these patients did not receive the appropriate targeted therapies.
Overall, around 64% of eligible patients with advanced NSCLC are not benefiting from the most appropriate therapies, the team concludes.
The research was published online in JCO Precision Oncology.
Gaps in clinical practice
The high rate of failure points to clinical practice gaps in “many areas” across the cancer care spectrum, lead author Daryl Pritchard, PhD, from the Personalized Medicine Coalition, Washington, told this news organization.
“There’s various steps along the way that affect clinicians, laboratories, payers, the health providers [and] even patients,” he said. He added that product manufacturers also “have a role.”
“So it’s not an individual group that’s causing the problem. It’s a systemic awareness and systemic need to improve the delivery process.”
Dr. Pritchard underlined that the “the main goal of this analysis is to put everybody on alert that we need to do something about it.
“We need to – and this is easy to say but hard to do – evolve health care from a traditional one-size-fits-all mentality to a value-based strategy where you’re saying we want the best treatments” for patients, he said.
This means developing optimized and standardized laboratory processes, as well as clinical guidelines that set out the standard of care and optimized and integrated clinical decision support.
“We need to work as a community to demonstrate the value of this care and improve education and awareness to providers and payers,” Dr. Pritchard said. “That will encourage value-based practice coverage and reimbursement policies, and then also incentivize utilization in validated cases.”
Julie R. Brahmer, MD, who directs the thoracic oncology program at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, who was not involved with the study, said she was not sure whether she would say she was “surprised or disheartened” by the findings.
The study was focused on advanced NSCLC patients treated in 2019. Dr. Brahmer wondered whether the COVID-19 pandemic “might actually have made things worse.”
It will be important to “drill down” into some of the reasons why 30% of patients for whom biomarker testing results were available did not receive the appropriate treatment, she said.
Aside from cost-related problems, one factor at play could be whether the patient saw an oncologist, she said, while another could be that they went “straight to hospice” and were “not healthy enough to be able to tolerate” their targeted therapy.
Greater use of liquid biopsies, which identify biomarkers in the blood, are one way to improve access to biomarker testing, she suggested. It would help if these liquid biopsies were “consistently paid for by the payer, particularly for patients with advanced disease,” she added. Currently, payers often want patients to first undergo a tissue biopsy, which involves lung aspiration and may not be possible for some patients.
“If a Medicare patient is in the hospital when they have their biopsy or surgery, and then they have to wait 14 days in order for mutation tests to be ordered, and then if you add another 2 weeks for that test to come back, or even longer … [These delays] are some of the reasons why patients didn’t end up receiving therapy,” she elaborated.
“Some of these patients just can’t last that long before starting treatment,” she said.
Sandip P. Patel, MD, an oncologist at the Precision Immunotherapy Clinic at the University of California, San Diego, in La Jolla, wondered whether the issue is lack of education among physicians or whether there are potential financial problems. “Is there a financial risk to patients, for example, that is not being captured?” he mused.
It could also be a question of urban vs. rural centers, language barriers in communicating to patients, or other social determinants of health, he added.
At his institution (UCSD), there are “multiple choices” of molecular tests, each with “little nuances that differ among the tests that folks sometimes will take a look at in term of picking the best.
“But the best test is the one that gets done, and here we’re seeing no testing at all” for many patients, he said.
“It’s really unfortunate because for a lot of these patients, not only are they not getting the latest therapy, but they’re often getting something else that’s expensive and toxic instead,” Dr. Patel said.
Referring to the relatively high proportion of patients who didn’t receive targeted therapy even after being tested, he said, “For me, this study leaves more questions and answers.
“We’ve seen a lot of work in this space, showing us the problem,” Dr. Patel said. “What I haven’t yet seen is a very discrete analysis of the cause of that problem upstream.”
Cornerstone of personalized medicine
In their article, Dr. Pritchard and colleagues note that more than 90 targeted therapies have been approved by the U.S. Food and Drug Administration for use in eligible cancer patients. An estimated 55% of recent oncology trials involved the use of biomarkers.
Predictive biomarker testing to identify patients who may benefit from targeted therapies “is a cornerstone of personalized medicine in cancer care, allowing for more rapid diagnosis while informing treatment decisions that could lead to better patient outcomes and systemic efficiencies,” they emphasize.
However, providers “face several challenges” when integrating biomarker testing and targeted therapeutics into cancer care, and the use of biomarker testing varies widely across tumor types, biomarkers, and practice settings.
For their study, the team examined the use of targeted therapy in advanced NSCLC using data from the Diaceutics Data Repository, which includes commercial and Medicare claims, as well as laboratory data.
They focused on 38,068 patients with actively managed advanced NSCLC. Of those patients, 50.80% were women, and 64.6% were aged 71 years or older. The vast majority (84.50%) were non-Hispanic White patients.
The team examined the impact of seven clinical practice gaps on the timeline from ordering a biopsy to delivering targeted treatment. They then normalized the results to a standard patient population of 1,000.
In 6.6% of cases, an initial tissue or liquid biopsy was never performed, meaning that 66 of the 1,000 patients could not progress toward targeted therapy.
Among those who underwent a biopsy, for 4.0%, there was insufficient tissue on the initial biopsy, while for a further 0.97%, there was insufficient tissue on re-biopsy. Moreover, 9.6% could not undergo biopsy testing because of a lack of tumor tissue. Consequently, a further 136 of the 944 remaining patients were lost.
For the third clinical practice gap, the tumor cell content was overestimated in 1.7% of patients. As a result, their biopsy specimen could not be tested because it did not meet the threshold requirements. This resulted in the loss of a further 14 patients.
Moreover, for a further 17.5% of patients, biomarker testing was not ordered at all, owing to cost concerns, a lack of access to testing, a lack of awareness of testing options, and low confidence in the results, among other reasons. An additional 0.6% began treatment before any testing was ordered; together, that accounted for 142 patients being lost.
Even among patients who underwent biomarker testing, 14.5% had uninformative or inconclusive results, and 3.9% had false-negative results, meaning that a further 118 patients were lost.
In another 4.0% of cases, the results of biomarker testing did not arrive within the treatment decision window, owing to delays in reporting the results, and so for these patients, treatment began without the results being taken into consideration. A further 21 patients were lost.
The final clinical practice gap was not choosing the appropriate targeted treatment on the basis of test results. The researchers found that of 27,186 patients who underwent biomarker testing and received a timely result, 29.2% were not given the corresponding therapy. This resulted in the loss of a further 147 of the original 1,000 patients.
Overall, the team calculated that 64.4% of patients newly diagnosed with advanced NSCLC “are not benefiting from precision oncology care options appropriate for their diseases and will likely have suboptimal outcomes.”
The research was supported in part by the Personalized Medicine Coalition, a nonprofit 501c3 organization dedicated to the advancement of personalized medicine. Dr. Pritchard is an employee of the Personalized Medicine Coalition. A coauthor has relationships with Thermo Fisher Scientific, AstraZeneca, Eli Lilly, Blueprint Medicines, and Oncocyte.
A version of this article first appeared on Medscape.com.
because of gaps in clinical practice all along the cancer care spectrum, reveals a new analysis of data from U.S. practices.
For some of these patients, it could mean missing the chance for long-term survival or even cure.
One lung cancer patient, Janet Freeman-Daily, recently tweeted that she entered a targeted therapy clinical trial 10 years ago and is still taking the same, now approved, oral drug, with “no evidence of disease.”
Patients who have lung cancer with mutations that can be targeted with drug therapies – but who do not receive them – are missing this opportunity.
The new study suggests that there are many such patients. The researchers analyzed data on more than 38,000 patients with actively managed advanced NSCLC. They found that about half did not receive biomarker test results for a variety of reasons. But even among the half who were successfully tested, 30% of these patients did not receive the appropriate targeted therapies.
Overall, around 64% of eligible patients with advanced NSCLC are not benefiting from the most appropriate therapies, the team concludes.
The research was published online in JCO Precision Oncology.
Gaps in clinical practice
The high rate of failure points to clinical practice gaps in “many areas” across the cancer care spectrum, lead author Daryl Pritchard, PhD, from the Personalized Medicine Coalition, Washington, told this news organization.
“There’s various steps along the way that affect clinicians, laboratories, payers, the health providers [and] even patients,” he said. He added that product manufacturers also “have a role.”
“So it’s not an individual group that’s causing the problem. It’s a systemic awareness and systemic need to improve the delivery process.”
Dr. Pritchard underlined that the “the main goal of this analysis is to put everybody on alert that we need to do something about it.
“We need to – and this is easy to say but hard to do – evolve health care from a traditional one-size-fits-all mentality to a value-based strategy where you’re saying we want the best treatments” for patients, he said.
This means developing optimized and standardized laboratory processes, as well as clinical guidelines that set out the standard of care and optimized and integrated clinical decision support.
“We need to work as a community to demonstrate the value of this care and improve education and awareness to providers and payers,” Dr. Pritchard said. “That will encourage value-based practice coverage and reimbursement policies, and then also incentivize utilization in validated cases.”
Julie R. Brahmer, MD, who directs the thoracic oncology program at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, who was not involved with the study, said she was not sure whether she would say she was “surprised or disheartened” by the findings.
The study was focused on advanced NSCLC patients treated in 2019. Dr. Brahmer wondered whether the COVID-19 pandemic “might actually have made things worse.”
It will be important to “drill down” into some of the reasons why 30% of patients for whom biomarker testing results were available did not receive the appropriate treatment, she said.
Aside from cost-related problems, one factor at play could be whether the patient saw an oncologist, she said, while another could be that they went “straight to hospice” and were “not healthy enough to be able to tolerate” their targeted therapy.
Greater use of liquid biopsies, which identify biomarkers in the blood, are one way to improve access to biomarker testing, she suggested. It would help if these liquid biopsies were “consistently paid for by the payer, particularly for patients with advanced disease,” she added. Currently, payers often want patients to first undergo a tissue biopsy, which involves lung aspiration and may not be possible for some patients.
“If a Medicare patient is in the hospital when they have their biopsy or surgery, and then they have to wait 14 days in order for mutation tests to be ordered, and then if you add another 2 weeks for that test to come back, or even longer … [These delays] are some of the reasons why patients didn’t end up receiving therapy,” she elaborated.
“Some of these patients just can’t last that long before starting treatment,” she said.
Sandip P. Patel, MD, an oncologist at the Precision Immunotherapy Clinic at the University of California, San Diego, in La Jolla, wondered whether the issue is lack of education among physicians or whether there are potential financial problems. “Is there a financial risk to patients, for example, that is not being captured?” he mused.
It could also be a question of urban vs. rural centers, language barriers in communicating to patients, or other social determinants of health, he added.
At his institution (UCSD), there are “multiple choices” of molecular tests, each with “little nuances that differ among the tests that folks sometimes will take a look at in term of picking the best.
“But the best test is the one that gets done, and here we’re seeing no testing at all” for many patients, he said.
“It’s really unfortunate because for a lot of these patients, not only are they not getting the latest therapy, but they’re often getting something else that’s expensive and toxic instead,” Dr. Patel said.
Referring to the relatively high proportion of patients who didn’t receive targeted therapy even after being tested, he said, “For me, this study leaves more questions and answers.
“We’ve seen a lot of work in this space, showing us the problem,” Dr. Patel said. “What I haven’t yet seen is a very discrete analysis of the cause of that problem upstream.”
Cornerstone of personalized medicine
In their article, Dr. Pritchard and colleagues note that more than 90 targeted therapies have been approved by the U.S. Food and Drug Administration for use in eligible cancer patients. An estimated 55% of recent oncology trials involved the use of biomarkers.
Predictive biomarker testing to identify patients who may benefit from targeted therapies “is a cornerstone of personalized medicine in cancer care, allowing for more rapid diagnosis while informing treatment decisions that could lead to better patient outcomes and systemic efficiencies,” they emphasize.
However, providers “face several challenges” when integrating biomarker testing and targeted therapeutics into cancer care, and the use of biomarker testing varies widely across tumor types, biomarkers, and practice settings.
For their study, the team examined the use of targeted therapy in advanced NSCLC using data from the Diaceutics Data Repository, which includes commercial and Medicare claims, as well as laboratory data.
They focused on 38,068 patients with actively managed advanced NSCLC. Of those patients, 50.80% were women, and 64.6% were aged 71 years or older. The vast majority (84.50%) were non-Hispanic White patients.
The team examined the impact of seven clinical practice gaps on the timeline from ordering a biopsy to delivering targeted treatment. They then normalized the results to a standard patient population of 1,000.
In 6.6% of cases, an initial tissue or liquid biopsy was never performed, meaning that 66 of the 1,000 patients could not progress toward targeted therapy.
Among those who underwent a biopsy, for 4.0%, there was insufficient tissue on the initial biopsy, while for a further 0.97%, there was insufficient tissue on re-biopsy. Moreover, 9.6% could not undergo biopsy testing because of a lack of tumor tissue. Consequently, a further 136 of the 944 remaining patients were lost.
For the third clinical practice gap, the tumor cell content was overestimated in 1.7% of patients. As a result, their biopsy specimen could not be tested because it did not meet the threshold requirements. This resulted in the loss of a further 14 patients.
Moreover, for a further 17.5% of patients, biomarker testing was not ordered at all, owing to cost concerns, a lack of access to testing, a lack of awareness of testing options, and low confidence in the results, among other reasons. An additional 0.6% began treatment before any testing was ordered; together, that accounted for 142 patients being lost.
Even among patients who underwent biomarker testing, 14.5% had uninformative or inconclusive results, and 3.9% had false-negative results, meaning that a further 118 patients were lost.
In another 4.0% of cases, the results of biomarker testing did not arrive within the treatment decision window, owing to delays in reporting the results, and so for these patients, treatment began without the results being taken into consideration. A further 21 patients were lost.
The final clinical practice gap was not choosing the appropriate targeted treatment on the basis of test results. The researchers found that of 27,186 patients who underwent biomarker testing and received a timely result, 29.2% were not given the corresponding therapy. This resulted in the loss of a further 147 of the original 1,000 patients.
Overall, the team calculated that 64.4% of patients newly diagnosed with advanced NSCLC “are not benefiting from precision oncology care options appropriate for their diseases and will likely have suboptimal outcomes.”
The research was supported in part by the Personalized Medicine Coalition, a nonprofit 501c3 organization dedicated to the advancement of personalized medicine. Dr. Pritchard is an employee of the Personalized Medicine Coalition. A coauthor has relationships with Thermo Fisher Scientific, AstraZeneca, Eli Lilly, Blueprint Medicines, and Oncocyte.
A version of this article first appeared on Medscape.com.
FDA requests more restrictions on ovarian cancer drugs
citing recent data showing an increased risk for death with the agents versus chemotherapy.
These restrictions could mean bankruptcy for one company.
Earlier this year, several companies voluntarily withdrew their respective PARP inhibitors for heavily pretreated patients with ovarian cancer in later-line indications.
Now, the FDA has asked GlaxoSmithKline and Clovis Oncology to restrict the second-line indications for their PARP inhibitors – niraparib (Zejula) for GSK and rucaparib (Rubraca) for Clovis.
The FDA’s requests are based on recent data showing an increased risk for death with the PARP inhibitors versus chemotherapy.
On Nov. 11, GSK announced that, at the FDA’s request, it will limit the second-line maintenance indication for its PARP inhibitor niraparib to patients with deleterious or suspected deleterious germline BRCA mutations.
The prescribing change was based on an FDA review of the final overall survival analysis of the NOVA phase 3 trial, which served as the basis for the approval of the second-line maintenance indication. The final overall survival data showed a hazard ratio of 1.06 (95% confidence interval, 0.81-1.37) in the cohort without germline BRCA mutations.
The company noted, however, that its first-line indication remains unchanged.
The FDA has also asked Clovis Oncology to restrict its PARP inhibitor rucaparib in the second-line maintenance therapy setting, according to a Nov. 14 U.S. Securities and Exchange Commission filing from the company. Rucaparib is currently not approved to treat ovarian cancer in the first-line setting.
According to the filing, the FDA met with Clovis Oncology to discuss the overall survival data from the ARIEL3 clinical trial, which formed the basis for the drug’s approval in the United States as second-line maintenance for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had a complete or partial response to platinum-based chemotherapy.
In September 2022, Clovis Oncology submitted the final overall survival data from the ARIEL3 trial to FDA. According to the company, among all populations analyzed, the confidence intervals for all hazard ratios crossed 1, “indicating no difference between the treatment arms.”
Based on the overall survival data, the FDA requested that Clovis “voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment” to only patients with BRCA mutations.
Clovis said it is “currently evaluating FDA’s request.” If an agreement can’t be reached, the FDA said it would convene an advisory committee to review the matter.
However, further restricting the indication for rucaparib could put the company’s future in jeopardy. In an earlier report, Clovis Oncology foreshadowed a “potential bankruptcy filing in the very near term” as “increasingly probable.”
The company explained that, because “a substantial portion” of the drug’s revenue is attributable to its second-line indication, limiting that indication “could result in a significant impact on our revenue.”
The report continued: “Based on our current cash and cash equivalents, together with current estimates for revenues to be generated by sales of Rubraca, we will not have sufficient liquidity to maintain our operations beyond January 2023.”
A version of this article first appeared on Medscape.com.
citing recent data showing an increased risk for death with the agents versus chemotherapy.
These restrictions could mean bankruptcy for one company.
Earlier this year, several companies voluntarily withdrew their respective PARP inhibitors for heavily pretreated patients with ovarian cancer in later-line indications.
Now, the FDA has asked GlaxoSmithKline and Clovis Oncology to restrict the second-line indications for their PARP inhibitors – niraparib (Zejula) for GSK and rucaparib (Rubraca) for Clovis.
The FDA’s requests are based on recent data showing an increased risk for death with the PARP inhibitors versus chemotherapy.
On Nov. 11, GSK announced that, at the FDA’s request, it will limit the second-line maintenance indication for its PARP inhibitor niraparib to patients with deleterious or suspected deleterious germline BRCA mutations.
The prescribing change was based on an FDA review of the final overall survival analysis of the NOVA phase 3 trial, which served as the basis for the approval of the second-line maintenance indication. The final overall survival data showed a hazard ratio of 1.06 (95% confidence interval, 0.81-1.37) in the cohort without germline BRCA mutations.
The company noted, however, that its first-line indication remains unchanged.
The FDA has also asked Clovis Oncology to restrict its PARP inhibitor rucaparib in the second-line maintenance therapy setting, according to a Nov. 14 U.S. Securities and Exchange Commission filing from the company. Rucaparib is currently not approved to treat ovarian cancer in the first-line setting.
According to the filing, the FDA met with Clovis Oncology to discuss the overall survival data from the ARIEL3 clinical trial, which formed the basis for the drug’s approval in the United States as second-line maintenance for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had a complete or partial response to platinum-based chemotherapy.
In September 2022, Clovis Oncology submitted the final overall survival data from the ARIEL3 trial to FDA. According to the company, among all populations analyzed, the confidence intervals for all hazard ratios crossed 1, “indicating no difference between the treatment arms.”
Based on the overall survival data, the FDA requested that Clovis “voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment” to only patients with BRCA mutations.
Clovis said it is “currently evaluating FDA’s request.” If an agreement can’t be reached, the FDA said it would convene an advisory committee to review the matter.
However, further restricting the indication for rucaparib could put the company’s future in jeopardy. In an earlier report, Clovis Oncology foreshadowed a “potential bankruptcy filing in the very near term” as “increasingly probable.”
The company explained that, because “a substantial portion” of the drug’s revenue is attributable to its second-line indication, limiting that indication “could result in a significant impact on our revenue.”
The report continued: “Based on our current cash and cash equivalents, together with current estimates for revenues to be generated by sales of Rubraca, we will not have sufficient liquidity to maintain our operations beyond January 2023.”
A version of this article first appeared on Medscape.com.
citing recent data showing an increased risk for death with the agents versus chemotherapy.
These restrictions could mean bankruptcy for one company.
Earlier this year, several companies voluntarily withdrew their respective PARP inhibitors for heavily pretreated patients with ovarian cancer in later-line indications.
Now, the FDA has asked GlaxoSmithKline and Clovis Oncology to restrict the second-line indications for their PARP inhibitors – niraparib (Zejula) for GSK and rucaparib (Rubraca) for Clovis.
The FDA’s requests are based on recent data showing an increased risk for death with the PARP inhibitors versus chemotherapy.
On Nov. 11, GSK announced that, at the FDA’s request, it will limit the second-line maintenance indication for its PARP inhibitor niraparib to patients with deleterious or suspected deleterious germline BRCA mutations.
The prescribing change was based on an FDA review of the final overall survival analysis of the NOVA phase 3 trial, which served as the basis for the approval of the second-line maintenance indication. The final overall survival data showed a hazard ratio of 1.06 (95% confidence interval, 0.81-1.37) in the cohort without germline BRCA mutations.
The company noted, however, that its first-line indication remains unchanged.
The FDA has also asked Clovis Oncology to restrict its PARP inhibitor rucaparib in the second-line maintenance therapy setting, according to a Nov. 14 U.S. Securities and Exchange Commission filing from the company. Rucaparib is currently not approved to treat ovarian cancer in the first-line setting.
According to the filing, the FDA met with Clovis Oncology to discuss the overall survival data from the ARIEL3 clinical trial, which formed the basis for the drug’s approval in the United States as second-line maintenance for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had a complete or partial response to platinum-based chemotherapy.
In September 2022, Clovis Oncology submitted the final overall survival data from the ARIEL3 trial to FDA. According to the company, among all populations analyzed, the confidence intervals for all hazard ratios crossed 1, “indicating no difference between the treatment arms.”
Based on the overall survival data, the FDA requested that Clovis “voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment” to only patients with BRCA mutations.
Clovis said it is “currently evaluating FDA’s request.” If an agreement can’t be reached, the FDA said it would convene an advisory committee to review the matter.
However, further restricting the indication for rucaparib could put the company’s future in jeopardy. In an earlier report, Clovis Oncology foreshadowed a “potential bankruptcy filing in the very near term” as “increasingly probable.”
The company explained that, because “a substantial portion” of the drug’s revenue is attributable to its second-line indication, limiting that indication “could result in a significant impact on our revenue.”
The report continued: “Based on our current cash and cash equivalents, together with current estimates for revenues to be generated by sales of Rubraca, we will not have sufficient liquidity to maintain our operations beyond January 2023.”
A version of this article first appeared on Medscape.com.
Axial Spondyloarthritis Highlights From ACR 2022
Reporting on highlights in axial spondyloarthritis (AxSpA) from the American College of Rheumatology Convergence 2022, Dr Philip Mease of Swedish Medical Center in Seattle calls attention to studies on promising therapeutic outcomes.
He begins with the late-breaking long-range therapeutic results of bimekizumab, which was shown to be effective in patients with nonradiographic AxSpA and those with ankylosing spondylitis over 52 weeks.
Next, he reports on a study examining withdrawal vs tapering of golimumab, which underscored the benefit of tapering in prevention of disease flares.
Dr Mease then discusses a study in which cycling between tumor necrosis factor inhibitors provided disappointing results in the AxSpA population, suggesting that switching to a therapy with a different mechanism of action might achieve better outcomes.
Another study cited by Dr Mease explored the use of combination therapy in patients with AxSpA, which yielded promising results. Should this approach take hold, Dr Mease says that in the future, "we'll be more like oncologists, mixing and matching and doing what's best for our patients to bring them into a state of remission."
Dr Mease closes by discussing a large study investigating COVID among patients with autoimmune diseases, including AxSpA and psoriasis. The study found that neither the conditions themselves nor their treatments significantly increased risk for severe outcomes.
--
Philip Mease, MD, Clinical Professor, University of Washington School of Medicine; Director, Department of Rheumatology Research, Swedish Medical Center/Providence St. Joseph's Health, Seattle Rheumatology Associates, Seattle, Washington
Philip Mease, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Acelyrin; Aclaris; Amgen; Boehringer Ingelheim; Bristol Myers Squibb; Eli Lilly; Galapagos; Gilead; GlaxoSmithKline; Inmagene; Janssen; MoonLake; Novartis; Pfizer; Sun Pharma; UCB
Serve(d) as a speaker or a member of a speakers bureau for: AbbVie; Amgen; Eli Lilly; Janssen; Novartis; Pfizer; UCB
Received research grant from: AbbVie; Amgen; Bristol Myers Squibb; Eli Lilly; Galapagos; Gilead; Janssen; Novartis; Pfizer; Sun Pharma; UCB
Reporting on highlights in axial spondyloarthritis (AxSpA) from the American College of Rheumatology Convergence 2022, Dr Philip Mease of Swedish Medical Center in Seattle calls attention to studies on promising therapeutic outcomes.
He begins with the late-breaking long-range therapeutic results of bimekizumab, which was shown to be effective in patients with nonradiographic AxSpA and those with ankylosing spondylitis over 52 weeks.
Next, he reports on a study examining withdrawal vs tapering of golimumab, which underscored the benefit of tapering in prevention of disease flares.
Dr Mease then discusses a study in which cycling between tumor necrosis factor inhibitors provided disappointing results in the AxSpA population, suggesting that switching to a therapy with a different mechanism of action might achieve better outcomes.
Another study cited by Dr Mease explored the use of combination therapy in patients with AxSpA, which yielded promising results. Should this approach take hold, Dr Mease says that in the future, "we'll be more like oncologists, mixing and matching and doing what's best for our patients to bring them into a state of remission."
Dr Mease closes by discussing a large study investigating COVID among patients with autoimmune diseases, including AxSpA and psoriasis. The study found that neither the conditions themselves nor their treatments significantly increased risk for severe outcomes.
--
Philip Mease, MD, Clinical Professor, University of Washington School of Medicine; Director, Department of Rheumatology Research, Swedish Medical Center/Providence St. Joseph's Health, Seattle Rheumatology Associates, Seattle, Washington
Philip Mease, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Acelyrin; Aclaris; Amgen; Boehringer Ingelheim; Bristol Myers Squibb; Eli Lilly; Galapagos; Gilead; GlaxoSmithKline; Inmagene; Janssen; MoonLake; Novartis; Pfizer; Sun Pharma; UCB
Serve(d) as a speaker or a member of a speakers bureau for: AbbVie; Amgen; Eli Lilly; Janssen; Novartis; Pfizer; UCB
Received research grant from: AbbVie; Amgen; Bristol Myers Squibb; Eli Lilly; Galapagos; Gilead; Janssen; Novartis; Pfizer; Sun Pharma; UCB
Reporting on highlights in axial spondyloarthritis (AxSpA) from the American College of Rheumatology Convergence 2022, Dr Philip Mease of Swedish Medical Center in Seattle calls attention to studies on promising therapeutic outcomes.
He begins with the late-breaking long-range therapeutic results of bimekizumab, which was shown to be effective in patients with nonradiographic AxSpA and those with ankylosing spondylitis over 52 weeks.
Next, he reports on a study examining withdrawal vs tapering of golimumab, which underscored the benefit of tapering in prevention of disease flares.
Dr Mease then discusses a study in which cycling between tumor necrosis factor inhibitors provided disappointing results in the AxSpA population, suggesting that switching to a therapy with a different mechanism of action might achieve better outcomes.
Another study cited by Dr Mease explored the use of combination therapy in patients with AxSpA, which yielded promising results. Should this approach take hold, Dr Mease says that in the future, "we'll be more like oncologists, mixing and matching and doing what's best for our patients to bring them into a state of remission."
Dr Mease closes by discussing a large study investigating COVID among patients with autoimmune diseases, including AxSpA and psoriasis. The study found that neither the conditions themselves nor their treatments significantly increased risk for severe outcomes.
--
Philip Mease, MD, Clinical Professor, University of Washington School of Medicine; Director, Department of Rheumatology Research, Swedish Medical Center/Providence St. Joseph's Health, Seattle Rheumatology Associates, Seattle, Washington
Philip Mease, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Acelyrin; Aclaris; Amgen; Boehringer Ingelheim; Bristol Myers Squibb; Eli Lilly; Galapagos; Gilead; GlaxoSmithKline; Inmagene; Janssen; MoonLake; Novartis; Pfizer; Sun Pharma; UCB
Serve(d) as a speaker or a member of a speakers bureau for: AbbVie; Amgen; Eli Lilly; Janssen; Novartis; Pfizer; UCB
Received research grant from: AbbVie; Amgen; Bristol Myers Squibb; Eli Lilly; Galapagos; Gilead; Janssen; Novartis; Pfizer; Sun Pharma; UCB
Managing trastuzumab deruxtecan adverse events in the real world
With recent expansions in its breast cancer indications, there has been an increase in the use of trastuzumab deruxtecan (T-DXd; Enhertu).
“A lot of us are using this more frequently now than we were in the past,” explained Sid Yadav, MD, a breast and gynecologic cancer specialist at the Mayo Clinic in Rochester, Minn. However, he added that managing its adverse events has been a “bit of a learning curve for all of us.”
The antibody-drug conjugate has been on the market since 2019 for metastatic human epidermal growth factor receptor (HER2)–positive breast cancer, but it was then approved in May 2022 for earlier use in this patient population and in August 2022 for patients with HER2-low disease. This latest approval was based on data showing an improvement in overall survival that was described as “practice changing.”
In addition, T-DXd is also approved for use in metastatic HER2-mutated non–small cell lung cancer and metastatic HER2-positive gastric and gastroesophageal junction adenocarcinoma.
, Dr. Yadav told this news organization.
Among the eight or so patients he’s seen or treated over 2 months, Dr. Yadav has already seen one case of high-grade interstitial lung disease/pneumonitis, a complication that “everybody worries about” because the label for T-DXd carries a black box warning of this possibility.
There have been other issues at Mayo Clinic, as well. In one recent week, five patients were admitted for possible T-DXd adverse events, including neutropenic fever and sepsis; pneumonitis; severe nausea/vomiting with electrolyte imbalance; pneumonia, and non–ST elevation myocardial infarction with low ejection fraction.
It’s unknown what proportion of T-DXd recipients the five admissions represented. Dr. Yadav’s service has over 10 breast oncologists, so the cases could represent maybe 1%-10% of patients, he said.
His experience prompted Dr. Yadav to turn to Twitter to ask fellow oncologists what complications they’ve seen with T-DXd.
One said that his “real-world toxicity experience [has been] worse than the trial data,” which isn’t unusual, another oncologist noted, because real-world patients are often sicker than trial participants and more vulnerable to toxicities.
A third oncologist countered that she has “found [T-DXd] generally easy for patients to tolerate and [has] not needed to admit anyone” so far.
Overall, Dr. Yadav said that in his experience there are issues that need to be considered with T-DXd beyond interstitial lung disease.
As with any chemotherapy, neutropenia and infections are a concern, as the labeling notes. The interstitial lung disease case has also made Dr. Yadav have a low threshold to order CT in patients with any hints of shortness of breath and to start steroids if there’s any suspicion.
Probably the most common issue, however, is nausea and vomiting. In clinical trials, over 70% of participants reported nausea and over 40% experienced vomiting.
In response, Dr. Yadav and his colleagues have become more aggressive with prophylaxis. Pretreatment includes steroids, palonosetron, and fosaprepitant. Patients are also usually sent home with prochlorperazine, ondansetron, and lorazepam. If these don’t help, the team considers olanzapine.
They have also learned that “it’s important to spend that extra 15-20 minutes upfront” with patients before starting T-DXd to explain the risk for nausea and vomiting and how it will be managed, Dr. Yadav commented. “We do chemotherapy teaching for every patient, but I think we spend more time [now] talking about nausea and vomiting with this subset,” he said.
Dr. Yadav still starts patients on the standard breast cancer dose of T-DXd – 5.4 mg/kg every 3 weeks – but said he’s quicker now to lower the dose if patients aren’t doing well. He estimates he’s done that a couple of times so far.
Approaches at the Mayo Clinic are in line with those in a recent article on managing T-DXd toxicities by Hope Rugo, MD, from the University of California, San Francisco, and colleagues.
These authors conclude that adverse events related to T-DXd are frequent but are most commonly low grade and manageable. Nausea and vomiting are among the most common, and they note that interstitial lung disease/pneumonitis is an important adverse event, for which proactive monitoring, diagnosis, and management are key.
The review describes management practices of other health care providers and institutions with experience in using T-DXd to help with safe and effective management of the drug’s adverse events, particularly since the duration of treatment may be quite long.
Proper management of T-DXd–related adverse events will allow optimal exposure to and benefit from the drug and will help avoid premature discontinuation or improper dose reductions, Dr. Rugo and colleagues commented.
Dr. Yadav reports no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
With recent expansions in its breast cancer indications, there has been an increase in the use of trastuzumab deruxtecan (T-DXd; Enhertu).
“A lot of us are using this more frequently now than we were in the past,” explained Sid Yadav, MD, a breast and gynecologic cancer specialist at the Mayo Clinic in Rochester, Minn. However, he added that managing its adverse events has been a “bit of a learning curve for all of us.”
The antibody-drug conjugate has been on the market since 2019 for metastatic human epidermal growth factor receptor (HER2)–positive breast cancer, but it was then approved in May 2022 for earlier use in this patient population and in August 2022 for patients with HER2-low disease. This latest approval was based on data showing an improvement in overall survival that was described as “practice changing.”
In addition, T-DXd is also approved for use in metastatic HER2-mutated non–small cell lung cancer and metastatic HER2-positive gastric and gastroesophageal junction adenocarcinoma.
, Dr. Yadav told this news organization.
Among the eight or so patients he’s seen or treated over 2 months, Dr. Yadav has already seen one case of high-grade interstitial lung disease/pneumonitis, a complication that “everybody worries about” because the label for T-DXd carries a black box warning of this possibility.
There have been other issues at Mayo Clinic, as well. In one recent week, five patients were admitted for possible T-DXd adverse events, including neutropenic fever and sepsis; pneumonitis; severe nausea/vomiting with electrolyte imbalance; pneumonia, and non–ST elevation myocardial infarction with low ejection fraction.
It’s unknown what proportion of T-DXd recipients the five admissions represented. Dr. Yadav’s service has over 10 breast oncologists, so the cases could represent maybe 1%-10% of patients, he said.
His experience prompted Dr. Yadav to turn to Twitter to ask fellow oncologists what complications they’ve seen with T-DXd.
One said that his “real-world toxicity experience [has been] worse than the trial data,” which isn’t unusual, another oncologist noted, because real-world patients are often sicker than trial participants and more vulnerable to toxicities.
A third oncologist countered that she has “found [T-DXd] generally easy for patients to tolerate and [has] not needed to admit anyone” so far.
Overall, Dr. Yadav said that in his experience there are issues that need to be considered with T-DXd beyond interstitial lung disease.
As with any chemotherapy, neutropenia and infections are a concern, as the labeling notes. The interstitial lung disease case has also made Dr. Yadav have a low threshold to order CT in patients with any hints of shortness of breath and to start steroids if there’s any suspicion.
Probably the most common issue, however, is nausea and vomiting. In clinical trials, over 70% of participants reported nausea and over 40% experienced vomiting.
In response, Dr. Yadav and his colleagues have become more aggressive with prophylaxis. Pretreatment includes steroids, palonosetron, and fosaprepitant. Patients are also usually sent home with prochlorperazine, ondansetron, and lorazepam. If these don’t help, the team considers olanzapine.
They have also learned that “it’s important to spend that extra 15-20 minutes upfront” with patients before starting T-DXd to explain the risk for nausea and vomiting and how it will be managed, Dr. Yadav commented. “We do chemotherapy teaching for every patient, but I think we spend more time [now] talking about nausea and vomiting with this subset,” he said.
Dr. Yadav still starts patients on the standard breast cancer dose of T-DXd – 5.4 mg/kg every 3 weeks – but said he’s quicker now to lower the dose if patients aren’t doing well. He estimates he’s done that a couple of times so far.
Approaches at the Mayo Clinic are in line with those in a recent article on managing T-DXd toxicities by Hope Rugo, MD, from the University of California, San Francisco, and colleagues.
These authors conclude that adverse events related to T-DXd are frequent but are most commonly low grade and manageable. Nausea and vomiting are among the most common, and they note that interstitial lung disease/pneumonitis is an important adverse event, for which proactive monitoring, diagnosis, and management are key.
The review describes management practices of other health care providers and institutions with experience in using T-DXd to help with safe and effective management of the drug’s adverse events, particularly since the duration of treatment may be quite long.
Proper management of T-DXd–related adverse events will allow optimal exposure to and benefit from the drug and will help avoid premature discontinuation or improper dose reductions, Dr. Rugo and colleagues commented.
Dr. Yadav reports no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
With recent expansions in its breast cancer indications, there has been an increase in the use of trastuzumab deruxtecan (T-DXd; Enhertu).
“A lot of us are using this more frequently now than we were in the past,” explained Sid Yadav, MD, a breast and gynecologic cancer specialist at the Mayo Clinic in Rochester, Minn. However, he added that managing its adverse events has been a “bit of a learning curve for all of us.”
The antibody-drug conjugate has been on the market since 2019 for metastatic human epidermal growth factor receptor (HER2)–positive breast cancer, but it was then approved in May 2022 for earlier use in this patient population and in August 2022 for patients with HER2-low disease. This latest approval was based on data showing an improvement in overall survival that was described as “practice changing.”
In addition, T-DXd is also approved for use in metastatic HER2-mutated non–small cell lung cancer and metastatic HER2-positive gastric and gastroesophageal junction adenocarcinoma.
, Dr. Yadav told this news organization.
Among the eight or so patients he’s seen or treated over 2 months, Dr. Yadav has already seen one case of high-grade interstitial lung disease/pneumonitis, a complication that “everybody worries about” because the label for T-DXd carries a black box warning of this possibility.
There have been other issues at Mayo Clinic, as well. In one recent week, five patients were admitted for possible T-DXd adverse events, including neutropenic fever and sepsis; pneumonitis; severe nausea/vomiting with electrolyte imbalance; pneumonia, and non–ST elevation myocardial infarction with low ejection fraction.
It’s unknown what proportion of T-DXd recipients the five admissions represented. Dr. Yadav’s service has over 10 breast oncologists, so the cases could represent maybe 1%-10% of patients, he said.
His experience prompted Dr. Yadav to turn to Twitter to ask fellow oncologists what complications they’ve seen with T-DXd.
One said that his “real-world toxicity experience [has been] worse than the trial data,” which isn’t unusual, another oncologist noted, because real-world patients are often sicker than trial participants and more vulnerable to toxicities.
A third oncologist countered that she has “found [T-DXd] generally easy for patients to tolerate and [has] not needed to admit anyone” so far.
Overall, Dr. Yadav said that in his experience there are issues that need to be considered with T-DXd beyond interstitial lung disease.
As with any chemotherapy, neutropenia and infections are a concern, as the labeling notes. The interstitial lung disease case has also made Dr. Yadav have a low threshold to order CT in patients with any hints of shortness of breath and to start steroids if there’s any suspicion.
Probably the most common issue, however, is nausea and vomiting. In clinical trials, over 70% of participants reported nausea and over 40% experienced vomiting.
In response, Dr. Yadav and his colleagues have become more aggressive with prophylaxis. Pretreatment includes steroids, palonosetron, and fosaprepitant. Patients are also usually sent home with prochlorperazine, ondansetron, and lorazepam. If these don’t help, the team considers olanzapine.
They have also learned that “it’s important to spend that extra 15-20 minutes upfront” with patients before starting T-DXd to explain the risk for nausea and vomiting and how it will be managed, Dr. Yadav commented. “We do chemotherapy teaching for every patient, but I think we spend more time [now] talking about nausea and vomiting with this subset,” he said.
Dr. Yadav still starts patients on the standard breast cancer dose of T-DXd – 5.4 mg/kg every 3 weeks – but said he’s quicker now to lower the dose if patients aren’t doing well. He estimates he’s done that a couple of times so far.
Approaches at the Mayo Clinic are in line with those in a recent article on managing T-DXd toxicities by Hope Rugo, MD, from the University of California, San Francisco, and colleagues.
These authors conclude that adverse events related to T-DXd are frequent but are most commonly low grade and manageable. Nausea and vomiting are among the most common, and they note that interstitial lung disease/pneumonitis is an important adverse event, for which proactive monitoring, diagnosis, and management are key.
The review describes management practices of other health care providers and institutions with experience in using T-DXd to help with safe and effective management of the drug’s adverse events, particularly since the duration of treatment may be quite long.
Proper management of T-DXd–related adverse events will allow optimal exposure to and benefit from the drug and will help avoid premature discontinuation or improper dose reductions, Dr. Rugo and colleagues commented.
Dr. Yadav reports no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Move faster, live longer? A little more effort goes a long way
If there’s one public health message Americans have heard loud and clear, it’s this one:
Move more.
Take more steps.
Spend more time doing physical activity – at least 150 minutes a week, according to the latest guidelines.
But hearing the message doesn’t mean we act on it. A whopping 25% of Americans don’t get any physical activity beyond what they do in their job, according to a CDC survey.
Just do what you’re already doing, but with a little more effort.
The study, which was published in the European Heart Journal, builds on growing evidence that suggests exercise intensity matters just as much as the amount. So, something as simple as turning a leisurely stroll into a brisk walk can, over time, lead to significant reductions in your risk of cardiovascular disease. No additional moves, steps, or minutes needed.
Step it up
Researchers at Cambridge University and the University of Leicester in England looked at data from 88,000 middle-aged adults who wore an activity tracking device for 7 days.
The devices tracked both the total amount of activity they did and the intensity of that movement – that is, how fast they walked or how hard they pushed themselves.
The researchers then calculated their physical activity energy expenditure (the number of calories they burned when they were up and moving) and the percentage that came from moderate to vigorous physical activity.
What’s the difference?
- Physical activity means any and every movement you do throughout the day. Mostly it’s mundane tasks like shopping, walking to the mailbox, playing with your dog, or cooking.
- Moderate-intensity physical activity includes things you do at a faster pace. Maybe you’re walking for exercise, doing yard work or household chores, or running late and just trying to get somewhere faster. You’re breathing a little harder and possibly working up a sweat.
- Vigorous-intensity physical activity is usually an exercise session – a run, a strenuous hike, a tough workout in the gym. It can also be an exhausting chore like shoveling snow, which feels like a workout. You’re definitely breathing harder, and you’re probably working up a sweat, even in the middle of winter.
Over the next 6 to 7 years, there were 4,000 new cases of cardiovascular disease among the people in the study.
Those who got at least 20% of their physical activity energy expenditure from moderate to vigorous activities had significantly less risk of heart disease, compared with those whose higher-effort activities were about 10%.
That was true even for those whose total activity was relatively low. As long as higher-effort activities reached 20% of their total, they were 14% less likely to be diagnosed with a heart condition.
And for those with relatively high activity levels, there was little extra benefit if their moderate and vigorous activities remained around 10%.
That finding surprised Paddy Dempsey, PhD, a medical research scientist at Cambridge and the study’s lead author. But it also makes sense.
“People can improve their cardiorespiratory fitness to a greater degree with higher-intensity activity,” he says. “More intensity will stress the system and lead to greater adaptation.”
The key is an increase in the amount of oxygen your heart and lungs can provide your muscles during exercise, a measure known as VO2max.
Raising your VO2max is the best way to reduce your risk of early death, especially death from heart disease. Simply moving up from the lowest conditioning category to a higher one will cut your risk of dying in any given year by as much as 60%.
Making strides
The study builds on previous research that shows the benefits of moving faster.
Walking faster will naturally increase your stride length, another predictor of longevity and future health. A review study published in 2021 found that older adults who took shorter steps were 26% more likely to have a disability, 34% more likely to have a major adverse event (like an injury that leads to a loss of independence), and 69% more likely to die over the next several years.
Quality versus quantity
We’ve focused so far on the quality of your physical activity – moving faster, taking longer strides.
But there’s still a lot to be said for movement quantity.
“It would be a mistake to say volume doesn’t matter,” Dr. Dempsey cautions.
A 2022 study in the journal The Lancet found that the risk of dying during a given period decreases with each increase in daily steps. The protective effect peaks at about 6,000 to 8,000 steps a day for adults 60 and over, and at 8,000 to 10,000 steps for those under 60.
“The relative value of the quality and quantity of exercise are very specific to a person’s goals,” says Chhanda Dutta, PhD, chief of the Clinical Gerontology Branch at the National Institute on Aging. “If performance is the goal, quality matters at least as much as quantity.”
Dr. Dempsey agrees that it’s not a cage match between two. Every step you take is a step in the right direction.
“People can choose or gravitate to an approach that works best for them,” he says. “It’s also helpful to think about where some everyday activities can be punctuated with intensity,” which could be as simple as walking faster when possible.
What matters most is that you choose something, Dr. Dutta says. “You have more to risk by not exercising.”
A version of this article first appeared on WebMD.com.
If there’s one public health message Americans have heard loud and clear, it’s this one:
Move more.
Take more steps.
Spend more time doing physical activity – at least 150 minutes a week, according to the latest guidelines.
But hearing the message doesn’t mean we act on it. A whopping 25% of Americans don’t get any physical activity beyond what they do in their job, according to a CDC survey.
Just do what you’re already doing, but with a little more effort.
The study, which was published in the European Heart Journal, builds on growing evidence that suggests exercise intensity matters just as much as the amount. So, something as simple as turning a leisurely stroll into a brisk walk can, over time, lead to significant reductions in your risk of cardiovascular disease. No additional moves, steps, or minutes needed.
Step it up
Researchers at Cambridge University and the University of Leicester in England looked at data from 88,000 middle-aged adults who wore an activity tracking device for 7 days.
The devices tracked both the total amount of activity they did and the intensity of that movement – that is, how fast they walked or how hard they pushed themselves.
The researchers then calculated their physical activity energy expenditure (the number of calories they burned when they were up and moving) and the percentage that came from moderate to vigorous physical activity.
What’s the difference?
- Physical activity means any and every movement you do throughout the day. Mostly it’s mundane tasks like shopping, walking to the mailbox, playing with your dog, or cooking.
- Moderate-intensity physical activity includes things you do at a faster pace. Maybe you’re walking for exercise, doing yard work or household chores, or running late and just trying to get somewhere faster. You’re breathing a little harder and possibly working up a sweat.
- Vigorous-intensity physical activity is usually an exercise session – a run, a strenuous hike, a tough workout in the gym. It can also be an exhausting chore like shoveling snow, which feels like a workout. You’re definitely breathing harder, and you’re probably working up a sweat, even in the middle of winter.
Over the next 6 to 7 years, there were 4,000 new cases of cardiovascular disease among the people in the study.
Those who got at least 20% of their physical activity energy expenditure from moderate to vigorous activities had significantly less risk of heart disease, compared with those whose higher-effort activities were about 10%.
That was true even for those whose total activity was relatively low. As long as higher-effort activities reached 20% of their total, they were 14% less likely to be diagnosed with a heart condition.
And for those with relatively high activity levels, there was little extra benefit if their moderate and vigorous activities remained around 10%.
That finding surprised Paddy Dempsey, PhD, a medical research scientist at Cambridge and the study’s lead author. But it also makes sense.
“People can improve their cardiorespiratory fitness to a greater degree with higher-intensity activity,” he says. “More intensity will stress the system and lead to greater adaptation.”
The key is an increase in the amount of oxygen your heart and lungs can provide your muscles during exercise, a measure known as VO2max.
Raising your VO2max is the best way to reduce your risk of early death, especially death from heart disease. Simply moving up from the lowest conditioning category to a higher one will cut your risk of dying in any given year by as much as 60%.
Making strides
The study builds on previous research that shows the benefits of moving faster.
Walking faster will naturally increase your stride length, another predictor of longevity and future health. A review study published in 2021 found that older adults who took shorter steps were 26% more likely to have a disability, 34% more likely to have a major adverse event (like an injury that leads to a loss of independence), and 69% more likely to die over the next several years.
Quality versus quantity
We’ve focused so far on the quality of your physical activity – moving faster, taking longer strides.
But there’s still a lot to be said for movement quantity.
“It would be a mistake to say volume doesn’t matter,” Dr. Dempsey cautions.
A 2022 study in the journal The Lancet found that the risk of dying during a given period decreases with each increase in daily steps. The protective effect peaks at about 6,000 to 8,000 steps a day for adults 60 and over, and at 8,000 to 10,000 steps for those under 60.
“The relative value of the quality and quantity of exercise are very specific to a person’s goals,” says Chhanda Dutta, PhD, chief of the Clinical Gerontology Branch at the National Institute on Aging. “If performance is the goal, quality matters at least as much as quantity.”
Dr. Dempsey agrees that it’s not a cage match between two. Every step you take is a step in the right direction.
“People can choose or gravitate to an approach that works best for them,” he says. “It’s also helpful to think about where some everyday activities can be punctuated with intensity,” which could be as simple as walking faster when possible.
What matters most is that you choose something, Dr. Dutta says. “You have more to risk by not exercising.”
A version of this article first appeared on WebMD.com.
If there’s one public health message Americans have heard loud and clear, it’s this one:
Move more.
Take more steps.
Spend more time doing physical activity – at least 150 minutes a week, according to the latest guidelines.
But hearing the message doesn’t mean we act on it. A whopping 25% of Americans don’t get any physical activity beyond what they do in their job, according to a CDC survey.
Just do what you’re already doing, but with a little more effort.
The study, which was published in the European Heart Journal, builds on growing evidence that suggests exercise intensity matters just as much as the amount. So, something as simple as turning a leisurely stroll into a brisk walk can, over time, lead to significant reductions in your risk of cardiovascular disease. No additional moves, steps, or minutes needed.
Step it up
Researchers at Cambridge University and the University of Leicester in England looked at data from 88,000 middle-aged adults who wore an activity tracking device for 7 days.
The devices tracked both the total amount of activity they did and the intensity of that movement – that is, how fast they walked or how hard they pushed themselves.
The researchers then calculated their physical activity energy expenditure (the number of calories they burned when they were up and moving) and the percentage that came from moderate to vigorous physical activity.
What’s the difference?
- Physical activity means any and every movement you do throughout the day. Mostly it’s mundane tasks like shopping, walking to the mailbox, playing with your dog, or cooking.
- Moderate-intensity physical activity includes things you do at a faster pace. Maybe you’re walking for exercise, doing yard work or household chores, or running late and just trying to get somewhere faster. You’re breathing a little harder and possibly working up a sweat.
- Vigorous-intensity physical activity is usually an exercise session – a run, a strenuous hike, a tough workout in the gym. It can also be an exhausting chore like shoveling snow, which feels like a workout. You’re definitely breathing harder, and you’re probably working up a sweat, even in the middle of winter.
Over the next 6 to 7 years, there were 4,000 new cases of cardiovascular disease among the people in the study.
Those who got at least 20% of their physical activity energy expenditure from moderate to vigorous activities had significantly less risk of heart disease, compared with those whose higher-effort activities were about 10%.
That was true even for those whose total activity was relatively low. As long as higher-effort activities reached 20% of their total, they were 14% less likely to be diagnosed with a heart condition.
And for those with relatively high activity levels, there was little extra benefit if their moderate and vigorous activities remained around 10%.
That finding surprised Paddy Dempsey, PhD, a medical research scientist at Cambridge and the study’s lead author. But it also makes sense.
“People can improve their cardiorespiratory fitness to a greater degree with higher-intensity activity,” he says. “More intensity will stress the system and lead to greater adaptation.”
The key is an increase in the amount of oxygen your heart and lungs can provide your muscles during exercise, a measure known as VO2max.
Raising your VO2max is the best way to reduce your risk of early death, especially death from heart disease. Simply moving up from the lowest conditioning category to a higher one will cut your risk of dying in any given year by as much as 60%.
Making strides
The study builds on previous research that shows the benefits of moving faster.
Walking faster will naturally increase your stride length, another predictor of longevity and future health. A review study published in 2021 found that older adults who took shorter steps were 26% more likely to have a disability, 34% more likely to have a major adverse event (like an injury that leads to a loss of independence), and 69% more likely to die over the next several years.
Quality versus quantity
We’ve focused so far on the quality of your physical activity – moving faster, taking longer strides.
But there’s still a lot to be said for movement quantity.
“It would be a mistake to say volume doesn’t matter,” Dr. Dempsey cautions.
A 2022 study in the journal The Lancet found that the risk of dying during a given period decreases with each increase in daily steps. The protective effect peaks at about 6,000 to 8,000 steps a day for adults 60 and over, and at 8,000 to 10,000 steps for those under 60.
“The relative value of the quality and quantity of exercise are very specific to a person’s goals,” says Chhanda Dutta, PhD, chief of the Clinical Gerontology Branch at the National Institute on Aging. “If performance is the goal, quality matters at least as much as quantity.”
Dr. Dempsey agrees that it’s not a cage match between two. Every step you take is a step in the right direction.
“People can choose or gravitate to an approach that works best for them,” he says. “It’s also helpful to think about where some everyday activities can be punctuated with intensity,” which could be as simple as walking faster when possible.
What matters most is that you choose something, Dr. Dutta says. “You have more to risk by not exercising.”
A version of this article first appeared on WebMD.com.
FROM EUROPEAN HEART JOURNAL
FDA rejects poziotinib for certain types of lung cancer
The clinical data the company submitted were deemed insufficient for approval, and additional data including a randomized clinical trial would be needed, the agency said.
The move is not a surprise, as the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9-4 against approval when it met to discuss the drug in September, as reported at the time by this news organization.
Poziotinib was developed for patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations, which occur in about 2% of patients with NSCLC.
Poziotinib is a potent oral pan-HER tyrosine kinase inhibitor with activity in patients with these mutations. Clinical data from the ZENITH20 Trial reported last year showed an overall response rate of 43.8%, and the drug was described as showing “clinically meaningful efficacy for treatment-naive NSCLC HER2 exon 20 mutations with [daily] dosing.”
“We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed,” commented Tom Riga, president and chief executive officer of Spectrum Pharmaceuticals.
However, following multiple interactions with the FDA, “we have made the strategic decision to immediately deprioritize the poziotinib program,” he said. The change is effective immediately, and the company is now in the process of reducing its R&D workforce by approximately 75%.
Drug development criticized
At the ODAC meeting, several panelists were openly critical of the approach Spectrum took in developing the drug. The FDA’s top cancer official, Richard Pazdur, MD, characterized Spectrum’s work as “poor drug development” and likened it to “building a house on quicksand.”
The FDA panel detailed several ways they felt that the poziotinib application fell short of the benchmarks needed for accelerated approval.
To win such a speedy clearance, a company needs to show that a drug provides a meaningful therapeutic benefit over existing treatments. The panel argued that, so far, poziotinib appears to be inferior to a product already available for HER2-mutant NSCLC, trastuzumab deruxtecan (Enhertu), which received accelerated approval in August.
The FDA staff contrasted a reported overall response rate for poziotinib, which was estimated at 28% (from data discussed at the meeting), with the overall response rate for trastuzumab deruxtecan, which is 58%.
Harpreet Singh, MD, a director in the FDA’s oncology division, asked the panel to consider what they would do as a physician treating a patient with this mutation, given the choices that are now available.
“That’s something we’re asking the committee to consider … to think about the context of what’s available to you in the clinic,” Dr. Singh said.
Dr. Singh said she expected that patients and physicians would prefer a drug such as trastuzumab deruxtecan, which has a more established record, regardless of the fact that treatment with poziotinib is more convenient because it is given as a tablet.
Dr. Singh and other staff also raised concerns about side effects of poziotinib, including diarrhea, as well as difficulty determining the right dose.
Katherine Scilla, MD, one of the nine ODAC panelists to vote “no,” echoed these views. Although Dr. Scilla, an oncologist at the University of Maryland, Baltimore, sympathized with the need for options for people with this rare form of lung cancer, she was not persuaded by the data on poziotinib that were presented to support accelerated approval.
“I’m not sure that this represents a meaningful therapeutic benefit over other agents,” she said at the time.
A version of this article first appeared on Medscape.com.
The clinical data the company submitted were deemed insufficient for approval, and additional data including a randomized clinical trial would be needed, the agency said.
The move is not a surprise, as the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9-4 against approval when it met to discuss the drug in September, as reported at the time by this news organization.
Poziotinib was developed for patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations, which occur in about 2% of patients with NSCLC.
Poziotinib is a potent oral pan-HER tyrosine kinase inhibitor with activity in patients with these mutations. Clinical data from the ZENITH20 Trial reported last year showed an overall response rate of 43.8%, and the drug was described as showing “clinically meaningful efficacy for treatment-naive NSCLC HER2 exon 20 mutations with [daily] dosing.”
“We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed,” commented Tom Riga, president and chief executive officer of Spectrum Pharmaceuticals.
However, following multiple interactions with the FDA, “we have made the strategic decision to immediately deprioritize the poziotinib program,” he said. The change is effective immediately, and the company is now in the process of reducing its R&D workforce by approximately 75%.
Drug development criticized
At the ODAC meeting, several panelists were openly critical of the approach Spectrum took in developing the drug. The FDA’s top cancer official, Richard Pazdur, MD, characterized Spectrum’s work as “poor drug development” and likened it to “building a house on quicksand.”
The FDA panel detailed several ways they felt that the poziotinib application fell short of the benchmarks needed for accelerated approval.
To win such a speedy clearance, a company needs to show that a drug provides a meaningful therapeutic benefit over existing treatments. The panel argued that, so far, poziotinib appears to be inferior to a product already available for HER2-mutant NSCLC, trastuzumab deruxtecan (Enhertu), which received accelerated approval in August.
The FDA staff contrasted a reported overall response rate for poziotinib, which was estimated at 28% (from data discussed at the meeting), with the overall response rate for trastuzumab deruxtecan, which is 58%.
Harpreet Singh, MD, a director in the FDA’s oncology division, asked the panel to consider what they would do as a physician treating a patient with this mutation, given the choices that are now available.
“That’s something we’re asking the committee to consider … to think about the context of what’s available to you in the clinic,” Dr. Singh said.
Dr. Singh said she expected that patients and physicians would prefer a drug such as trastuzumab deruxtecan, which has a more established record, regardless of the fact that treatment with poziotinib is more convenient because it is given as a tablet.
Dr. Singh and other staff also raised concerns about side effects of poziotinib, including diarrhea, as well as difficulty determining the right dose.
Katherine Scilla, MD, one of the nine ODAC panelists to vote “no,” echoed these views. Although Dr. Scilla, an oncologist at the University of Maryland, Baltimore, sympathized with the need for options for people with this rare form of lung cancer, she was not persuaded by the data on poziotinib that were presented to support accelerated approval.
“I’m not sure that this represents a meaningful therapeutic benefit over other agents,” she said at the time.
A version of this article first appeared on Medscape.com.
The clinical data the company submitted were deemed insufficient for approval, and additional data including a randomized clinical trial would be needed, the agency said.
The move is not a surprise, as the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9-4 against approval when it met to discuss the drug in September, as reported at the time by this news organization.
Poziotinib was developed for patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations, which occur in about 2% of patients with NSCLC.
Poziotinib is a potent oral pan-HER tyrosine kinase inhibitor with activity in patients with these mutations. Clinical data from the ZENITH20 Trial reported last year showed an overall response rate of 43.8%, and the drug was described as showing “clinically meaningful efficacy for treatment-naive NSCLC HER2 exon 20 mutations with [daily] dosing.”
“We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed,” commented Tom Riga, president and chief executive officer of Spectrum Pharmaceuticals.
However, following multiple interactions with the FDA, “we have made the strategic decision to immediately deprioritize the poziotinib program,” he said. The change is effective immediately, and the company is now in the process of reducing its R&D workforce by approximately 75%.
Drug development criticized
At the ODAC meeting, several panelists were openly critical of the approach Spectrum took in developing the drug. The FDA’s top cancer official, Richard Pazdur, MD, characterized Spectrum’s work as “poor drug development” and likened it to “building a house on quicksand.”
The FDA panel detailed several ways they felt that the poziotinib application fell short of the benchmarks needed for accelerated approval.
To win such a speedy clearance, a company needs to show that a drug provides a meaningful therapeutic benefit over existing treatments. The panel argued that, so far, poziotinib appears to be inferior to a product already available for HER2-mutant NSCLC, trastuzumab deruxtecan (Enhertu), which received accelerated approval in August.
The FDA staff contrasted a reported overall response rate for poziotinib, which was estimated at 28% (from data discussed at the meeting), with the overall response rate for trastuzumab deruxtecan, which is 58%.
Harpreet Singh, MD, a director in the FDA’s oncology division, asked the panel to consider what they would do as a physician treating a patient with this mutation, given the choices that are now available.
“That’s something we’re asking the committee to consider … to think about the context of what’s available to you in the clinic,” Dr. Singh said.
Dr. Singh said she expected that patients and physicians would prefer a drug such as trastuzumab deruxtecan, which has a more established record, regardless of the fact that treatment with poziotinib is more convenient because it is given as a tablet.
Dr. Singh and other staff also raised concerns about side effects of poziotinib, including diarrhea, as well as difficulty determining the right dose.
Katherine Scilla, MD, one of the nine ODAC panelists to vote “no,” echoed these views. Although Dr. Scilla, an oncologist at the University of Maryland, Baltimore, sympathized with the need for options for people with this rare form of lung cancer, she was not persuaded by the data on poziotinib that were presented to support accelerated approval.
“I’m not sure that this represents a meaningful therapeutic benefit over other agents,” she said at the time.
A version of this article first appeared on Medscape.com.
Lung cancer screening pushes 20-year survival rate to 80%
CHICAGO – , findings from a 20-year international study indicate.
Claudia Henschke, MD, PhD, professor of radiology and director of the Early Lung and Cardiac Action Program at the Icahn School of Medicine at Mount Sinai, New York, presented research results at the annual meeting of the Radiological Society of North America.
The researchers studied lung-cancer–specific survival (LCS) of 87,416 participants enrolled in an international, prospective study named the International Early Lung Cancer Action Program.
Lung cancer is the leading cause of cancer death. The American Lung Association states the average 5-year survival rate is 18.6%. Only 16% of the cancers are caught early and more than half of people with lung cancer die within a year of diagnosis.
Participants’ 20-year survival rate 80%
Results of this large international study showed the overall 20-year survival rate for the 1,285 screening participants diagnosed with early-stage cancer was 80% (95% confidence interval, 77%-83%). Among the 1,285 diagnosed, 83% had stage 1 cancer, Dr. Henschke said.
Lung cancer survival (LCS) was 100% for the 139 participants with nonsolid nodule consistency and for the 155 participants with part-solid consistency. LCS was 73% (95% CI, 69%-77%) for the 991 with solid consistency, and for clinical stage IA participants LCS was 86% (95% CI, 83%-89%), regardless of consistency.
For participants with pathologic stage IA lung cancer 10 mm or less in average diameter, the 20-year survival rate with identification and resection was 92% (95% CI, 87%-96%).
No lung cancer deaths were identified in the part-solid and nonsolid cancers, the researchers report.
These results show the 10-year findings from 2006 published in the New England Journal of Medicine, which also showed 80% survival rates with low-dose CT, have persisted, she said.
At the time of the 2006 paper, 95% of Americans diagnosed with lung cancer died from it, Dr. Henschke said.
Dr. Henschke notes that by the time symptoms appear, lung cancer is often advanced, so the best tool for detecting early-stage lung cancer is enrolling in an annual screening program.
When cancer is small enough and can be surgically removed, patients can be effectively cured long-term, she said.
“In the future, perhaps blood markers will allow us to detect it in the first half of the life cycle of lung cancer instead of CT at the beginning of the second half of the life cycle,” Dr. Henschke said.
“The study raises the power of prospective data collection in the context of clinical care as recommended by the Institute of Medicine long ago,” she said.
Findings “very promising”
Ernest Hawk, MD, MPH, head of the division of cancer prevention and population sciences at the University of Texas MD Anderson Cancer, Houston, told this news organization the findings look “very promising.” Dr. Hawk was not involved in the study.
“This was one of the earliest studies to evaluate low-dose CT scanning. Their report that the initial benefits seem to be holding up over a longer period of observation is great,” he said.
“This bolsters the data that lung cancer screening is beneficial over a longer period of observation,” he said, noting that most of the randomized controlled trials have been shorter.
Lung cancer screening is now recommended for high-risk individuals – those with at least a 20-pack-year history of tobacco use who are between 50 and 80 years old.
So far, screening is still limited to people at high risk, Dr. Hawk said, though there’s discussion about whether benefit would extend to people exposed to asbestos, for instance, or secondhand smoke.
“The biggest challenge right now is getting the screening to those who actually meet the criteria,” Dr. Hawk said.
Medscape reported earlier this month that less than 6% of high-risk smokers have the recommended annual lung cancer screening, according to a new report from the American Lung Association.
Dr. Henschke is on the Advisory Board for LungLifeAI and is on the board for the Early Diagnosis and Treatment Research Foundation. Dr. Hawk reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – , findings from a 20-year international study indicate.
Claudia Henschke, MD, PhD, professor of radiology and director of the Early Lung and Cardiac Action Program at the Icahn School of Medicine at Mount Sinai, New York, presented research results at the annual meeting of the Radiological Society of North America.
The researchers studied lung-cancer–specific survival (LCS) of 87,416 participants enrolled in an international, prospective study named the International Early Lung Cancer Action Program.
Lung cancer is the leading cause of cancer death. The American Lung Association states the average 5-year survival rate is 18.6%. Only 16% of the cancers are caught early and more than half of people with lung cancer die within a year of diagnosis.
Participants’ 20-year survival rate 80%
Results of this large international study showed the overall 20-year survival rate for the 1,285 screening participants diagnosed with early-stage cancer was 80% (95% confidence interval, 77%-83%). Among the 1,285 diagnosed, 83% had stage 1 cancer, Dr. Henschke said.
Lung cancer survival (LCS) was 100% for the 139 participants with nonsolid nodule consistency and for the 155 participants with part-solid consistency. LCS was 73% (95% CI, 69%-77%) for the 991 with solid consistency, and for clinical stage IA participants LCS was 86% (95% CI, 83%-89%), regardless of consistency.
For participants with pathologic stage IA lung cancer 10 mm or less in average diameter, the 20-year survival rate with identification and resection was 92% (95% CI, 87%-96%).
No lung cancer deaths were identified in the part-solid and nonsolid cancers, the researchers report.
These results show the 10-year findings from 2006 published in the New England Journal of Medicine, which also showed 80% survival rates with low-dose CT, have persisted, she said.
At the time of the 2006 paper, 95% of Americans diagnosed with lung cancer died from it, Dr. Henschke said.
Dr. Henschke notes that by the time symptoms appear, lung cancer is often advanced, so the best tool for detecting early-stage lung cancer is enrolling in an annual screening program.
When cancer is small enough and can be surgically removed, patients can be effectively cured long-term, she said.
“In the future, perhaps blood markers will allow us to detect it in the first half of the life cycle of lung cancer instead of CT at the beginning of the second half of the life cycle,” Dr. Henschke said.
“The study raises the power of prospective data collection in the context of clinical care as recommended by the Institute of Medicine long ago,” she said.
Findings “very promising”
Ernest Hawk, MD, MPH, head of the division of cancer prevention and population sciences at the University of Texas MD Anderson Cancer, Houston, told this news organization the findings look “very promising.” Dr. Hawk was not involved in the study.
“This was one of the earliest studies to evaluate low-dose CT scanning. Their report that the initial benefits seem to be holding up over a longer period of observation is great,” he said.
“This bolsters the data that lung cancer screening is beneficial over a longer period of observation,” he said, noting that most of the randomized controlled trials have been shorter.
Lung cancer screening is now recommended for high-risk individuals – those with at least a 20-pack-year history of tobacco use who are between 50 and 80 years old.
So far, screening is still limited to people at high risk, Dr. Hawk said, though there’s discussion about whether benefit would extend to people exposed to asbestos, for instance, or secondhand smoke.
“The biggest challenge right now is getting the screening to those who actually meet the criteria,” Dr. Hawk said.
Medscape reported earlier this month that less than 6% of high-risk smokers have the recommended annual lung cancer screening, according to a new report from the American Lung Association.
Dr. Henschke is on the Advisory Board for LungLifeAI and is on the board for the Early Diagnosis and Treatment Research Foundation. Dr. Hawk reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – , findings from a 20-year international study indicate.
Claudia Henschke, MD, PhD, professor of radiology and director of the Early Lung and Cardiac Action Program at the Icahn School of Medicine at Mount Sinai, New York, presented research results at the annual meeting of the Radiological Society of North America.
The researchers studied lung-cancer–specific survival (LCS) of 87,416 participants enrolled in an international, prospective study named the International Early Lung Cancer Action Program.
Lung cancer is the leading cause of cancer death. The American Lung Association states the average 5-year survival rate is 18.6%. Only 16% of the cancers are caught early and more than half of people with lung cancer die within a year of diagnosis.
Participants’ 20-year survival rate 80%
Results of this large international study showed the overall 20-year survival rate for the 1,285 screening participants diagnosed with early-stage cancer was 80% (95% confidence interval, 77%-83%). Among the 1,285 diagnosed, 83% had stage 1 cancer, Dr. Henschke said.
Lung cancer survival (LCS) was 100% for the 139 participants with nonsolid nodule consistency and for the 155 participants with part-solid consistency. LCS was 73% (95% CI, 69%-77%) for the 991 with solid consistency, and for clinical stage IA participants LCS was 86% (95% CI, 83%-89%), regardless of consistency.
For participants with pathologic stage IA lung cancer 10 mm or less in average diameter, the 20-year survival rate with identification and resection was 92% (95% CI, 87%-96%).
No lung cancer deaths were identified in the part-solid and nonsolid cancers, the researchers report.
These results show the 10-year findings from 2006 published in the New England Journal of Medicine, which also showed 80% survival rates with low-dose CT, have persisted, she said.
At the time of the 2006 paper, 95% of Americans diagnosed with lung cancer died from it, Dr. Henschke said.
Dr. Henschke notes that by the time symptoms appear, lung cancer is often advanced, so the best tool for detecting early-stage lung cancer is enrolling in an annual screening program.
When cancer is small enough and can be surgically removed, patients can be effectively cured long-term, she said.
“In the future, perhaps blood markers will allow us to detect it in the first half of the life cycle of lung cancer instead of CT at the beginning of the second half of the life cycle,” Dr. Henschke said.
“The study raises the power of prospective data collection in the context of clinical care as recommended by the Institute of Medicine long ago,” she said.
Findings “very promising”
Ernest Hawk, MD, MPH, head of the division of cancer prevention and population sciences at the University of Texas MD Anderson Cancer, Houston, told this news organization the findings look “very promising.” Dr. Hawk was not involved in the study.
“This was one of the earliest studies to evaluate low-dose CT scanning. Their report that the initial benefits seem to be holding up over a longer period of observation is great,” he said.
“This bolsters the data that lung cancer screening is beneficial over a longer period of observation,” he said, noting that most of the randomized controlled trials have been shorter.
Lung cancer screening is now recommended for high-risk individuals – those with at least a 20-pack-year history of tobacco use who are between 50 and 80 years old.
So far, screening is still limited to people at high risk, Dr. Hawk said, though there’s discussion about whether benefit would extend to people exposed to asbestos, for instance, or secondhand smoke.
“The biggest challenge right now is getting the screening to those who actually meet the criteria,” Dr. Hawk said.
Medscape reported earlier this month that less than 6% of high-risk smokers have the recommended annual lung cancer screening, according to a new report from the American Lung Association.
Dr. Henschke is on the Advisory Board for LungLifeAI and is on the board for the Early Diagnosis and Treatment Research Foundation. Dr. Hawk reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT RSNA 2022
Atezolizumab (Tecentriq) bladder cancer indication withdrawn in United States
The drug is an anti–PD-L1 inhibitor immunotherapy, and continues to be approved for use in lung and liver cancer and melanoma.
The manufacturer, Genentech, announced that it was voluntarily withdrawing the U.S. indication for atezolizumab that covered its use in adults with locally advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
The company said that it made the decision after consultation with the Food and Drug Administration.
“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner,” said Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development.
Atezolizumab had been granted an accelerated approval for this indication back in 2016, based on response rate data from the IMvigor210 trial.
The company was obliged to conduct a follow-up trial to show clinical benefit, and launched IMvigor130, which it described as “the designated postmarketing requirement to convert the accelerated approval to regular approval.”
The bladder cancer indication for atezolizumab was discussed (alongside several other indications for different immunotherapy drugs) at a historic 3-day meeting of the FDA’s oncologic Drugs Advisory Committee in April 2021. At the time, ODAC voted 10-1 in favor of maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.
Genentech has now said that this trial “did not meet the coprimary endpoint of overall survival for atezolizumab plus chemotherapy compared with chemotherapy alone” when used for the first-line treatment of patients with previously untreated advanced bladder cancer.
These data will be presented at an upcoming medical meeting, the company added.
“There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival,” Dr. Garraway commented.
A version of this article first appeared on Medscape.com.
The drug is an anti–PD-L1 inhibitor immunotherapy, and continues to be approved for use in lung and liver cancer and melanoma.
The manufacturer, Genentech, announced that it was voluntarily withdrawing the U.S. indication for atezolizumab that covered its use in adults with locally advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
The company said that it made the decision after consultation with the Food and Drug Administration.
“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner,” said Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development.
Atezolizumab had been granted an accelerated approval for this indication back in 2016, based on response rate data from the IMvigor210 trial.
The company was obliged to conduct a follow-up trial to show clinical benefit, and launched IMvigor130, which it described as “the designated postmarketing requirement to convert the accelerated approval to regular approval.”
The bladder cancer indication for atezolizumab was discussed (alongside several other indications for different immunotherapy drugs) at a historic 3-day meeting of the FDA’s oncologic Drugs Advisory Committee in April 2021. At the time, ODAC voted 10-1 in favor of maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.
Genentech has now said that this trial “did not meet the coprimary endpoint of overall survival for atezolizumab plus chemotherapy compared with chemotherapy alone” when used for the first-line treatment of patients with previously untreated advanced bladder cancer.
These data will be presented at an upcoming medical meeting, the company added.
“There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival,” Dr. Garraway commented.
A version of this article first appeared on Medscape.com.
The drug is an anti–PD-L1 inhibitor immunotherapy, and continues to be approved for use in lung and liver cancer and melanoma.
The manufacturer, Genentech, announced that it was voluntarily withdrawing the U.S. indication for atezolizumab that covered its use in adults with locally advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
The company said that it made the decision after consultation with the Food and Drug Administration.
“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner,” said Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development.
Atezolizumab had been granted an accelerated approval for this indication back in 2016, based on response rate data from the IMvigor210 trial.
The company was obliged to conduct a follow-up trial to show clinical benefit, and launched IMvigor130, which it described as “the designated postmarketing requirement to convert the accelerated approval to regular approval.”
The bladder cancer indication for atezolizumab was discussed (alongside several other indications for different immunotherapy drugs) at a historic 3-day meeting of the FDA’s oncologic Drugs Advisory Committee in April 2021. At the time, ODAC voted 10-1 in favor of maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.
Genentech has now said that this trial “did not meet the coprimary endpoint of overall survival for atezolizumab plus chemotherapy compared with chemotherapy alone” when used for the first-line treatment of patients with previously untreated advanced bladder cancer.
These data will be presented at an upcoming medical meeting, the company added.
“There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival,” Dr. Garraway commented.
A version of this article first appeared on Medscape.com.
FDA OKs first fecal transplant therapy for recurrent C. difficile
Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.
As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.
A panel of FDA advisors recommended approval of Rebyota in September.
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
A vicious cycle
Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.
Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.
In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.
The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.
Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.
The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.
“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.
Dr. Malter acknowledged that because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.
However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” Dr. Malter said.
Full prescribing information for Rebyota is available online.
Dr. Malter reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.
As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.
A panel of FDA advisors recommended approval of Rebyota in September.
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
A vicious cycle
Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.
Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.
In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.
The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.
Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.
The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.
“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.
Dr. Malter acknowledged that because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.
However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” Dr. Malter said.
Full prescribing information for Rebyota is available online.
Dr. Malter reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.
As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.
A panel of FDA advisors recommended approval of Rebyota in September.
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
A vicious cycle
Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.
Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.
In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.
The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.
Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.
The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.
“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.
Dr. Malter acknowledged that because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.
However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” Dr. Malter said.
Full prescribing information for Rebyota is available online.
Dr. Malter reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The TikTok trend that triggered a diabetes drug shortage
Weight loss advice is everywhere you look on social media, but one trend sweeping TikTok has led to shortages of an important diabetes drug.
Ozempic, a weekly injection that helps boost insulin sensitivity in people with type 2 diabetes, also suppresses appetite, which leads to weight loss. Stories of celebrities using the drug off-label to lose a few pounds have led to an explosion of interest. And now people with diabetes – people whose lives could be saved by the drug – are having trouble finding it.
Kim Kardashian and Elon Musk
In the spring, Kim Kardashian pulled off a dramatic weight loss to fit into Marilyn Monroe’s dress for the Met Gala. Soon rumors began to circulate that she’d used Ozempic to do it. Just this week, new Twitter owner Elon Musk tweeted about his own use of Ozempic and its sibling drug, Wegovy.
Variety dubbed Ozempic “the worst kept secret in Hollywood – especially given that its most enthusiastic users are not prediabetic and do not require the drug.” The rich and famous are spending $1,200 to $1,500 a month to get access.
As so often happens, high-profile use sparked a trend. Videos on TikTok hashtagged #ozempic have amassed more than 275 million views, and #ozempicweightloss has more than 110 million.
This raises concerns about who, exactly, is watching these videos, and what message they’re receiving.
“Forty-two percent of Americans have obesity, and even more have overweight. That’s affecting our younger people and our adolescents,” says Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at the Brigham and Women’s Hospital in Boston. “They’re looking at TikTok and other social media outlets for help.”
A new study shows how damaging this can be: Researchers analyzed 1,000 videos with nutrition, food, and weight-related hashtags, with over 1 billion views combined. They found that nearly all included messages glorifying weight loss and thinness.
At last, an effective weight-loss drug
Ozempic is Danish drug company Novo Nordisk’s brand name for semaglutide, which works by mimicking a naturally occurring hormone known as GLP-1. It travels to your brain and helps you feel full on less food. That leads to weight loss. In one 68-week study, semaglutide helped people lose an average of 15% of their body weight. But it’s not a miracle drug: You still have to change your eating habits and stay physically active.
The FDA approved Ozempic to treat people with type 2 diabetes in 2017. Four years later, Novo Nordisk received the green light for a higher-dose version meant specifically for people with obesity. Wegovy is approved for use only if you have a BMI of at least 27 with one or more weight-related ailments, or a BMI of 30 or more with none.
“These drugs are dominating my practice, because they’re so effective,” says Amanda Velazquez, MD, director of obesity medicine at Cedars-Sinai Medical Center in Los Angeles. The drug is considered safe, “so the majority of patients are good candidates.”
More demand than supply
As word spread about how well Ozempic and Wegovy worked, social media posts helped drive even more people to seek out the drugs. Now demand is outpacing the supply – according to the FDA, starter doses of Ozempic will have limited availability through January.
“In Hollywood, people are losing 10 pounds, getting it for $1,500 a month, and depleting stores for people who have such severe obesity that they have congestive heart failure and diabetes,” Dr. Apovian says. “These are people who are going to die, and you’re taking it away just for cosmetic weight loss. That is deplorable.”
In addition to huge demand, Wegovy also had a disruption in its supply chain. Right now, it isn’t available at all in lower doses, which is helping to spike off-label demand for Ozempic. Novo Nordisk expects to have these problems sorted out by the end of the year, with distribution following soon after.
The price of access
With a list price of $1,350 a month, Wegovy costs as much as many mortgages. And Medicaid, Medicare, and many insurance companies don’t cover it. Although obesity is a disease, the insurance industry treats weight loss as more of a vanity issue – so even if you could find the drug, you might not be able to afford it.
“We’re seeing that roughly half the prescriptions we write aren’t being covered,” Dr. Apovian says. “And for the half that are covered, we have to do prior authorization, which takes days, and it’s laborious.” In some instances, she says, insurance companies withdraw authorization after 3 months if they don’t see enough weight coming off.
It’s not like you can take Wegovy for 3 months, lose some weight, and expect it to stay off, either. The medication requires a real commitment, potentially for life. That’s because once the semaglutide leaves your system, your appetite returns. In one study, people regained two-thirds of the weight they’d lost within a year of stopping.
Many see a double standard in the insurance companies’ refusal to cover a drug that could prevent serious illness or death.
“They’re saying it’s not cost-effective to give the 42% of Americans who have a BMI over 30 Wegovy. Did they say this when statins came out?” Dr. Apovian says. “Why are they doing this with antiobesity agents? It’s the culture. The culture isn’t ready to adopt obesity as the disease that it is.”
Unpleasant side effects
Let’s assume you’re one of the lucky ones – your insurance covers Wegovy, and you can actually find some. You might discover that using it is no walk in the park. Common side effects include gastrointestinal issues like nausea, vomiting, and diarrhea.
“The way we counteract that is to start very slowly at a low dose of these medications,” Dr. Apovian says. “We only go up when the patient doesn’t have nausea or it gets better.”
Elise Davenport was excited to try Wegovy. “I did my online research. I’m the type who’s interested in early adoption, tech gadgets and stuff,” says the 40-year-old technical writer. “I wanted to try it because I’d tried so many other things that failed, or hadn’t worked long-term.”
With a BMI over 30, Ms. Davenport qualified for the drug. She signed up for an online program that guaranteed insurance coverage and started taking it in October 2021. At first, the side effects were mild, just a touch of nausea and diarrhea. And the results were impressive. She found it easy to feel satisfied with smaller portions and lost her cravings for sugar and highly processed foods. The weight fell off, roughly 5 pounds a week.
It turns out, that’s too much, too fast. Dr. Apovian and Dr. Velazquez say their patients lose more like 2 pounds each week, with careful monitoring.
By early December, Ms. Davenport’s side effects were ramping up. Because of shortages in lower dosages, the online program wasn’t able to adjust hers right away. She felt nauseated all the time, bad enough that brushing her teeth made her vomit and she had to force herself to eat. Some weeks, she managed less than 500 calories a day. Her sleep patterns became erratic. And then her depression, which medication had kept under control for years, spiraled.
“I remember sitting on the floor of my bathroom crying, thinking I’d rather carry the extra weight,” she says. “I used to take a lot of enjoyment from food, and I had none of that anymore. It was such a joyless experience at that point.”
Eventually, her dosage was reduced and the symptoms let up, but her primary care doctor encouraged her to stop. By the time she did, in March, she’d lost 55 pounds. So far, she’s gained back about 10.
More than just weight loss
Even though Ms. Davenport’s experience wasn’t a good one, with better monitoring, she’d be willing to try again. For one thing, seeing how easy it was to eat less with medical help helped to undo years of shame.
“Our culture treats obesity like a moral failing. I realized I’d been made to feel that way by doctors and programs – that I wasn’t doing enough,” she says. “This drug made me realize there are legit physiological things going on in my body, things that are often excluded from the conversation.”
Dr. Apovian and Dr. Velazquez say their patients regularly discover similar things.
“Obesity is not a disease of willpower. Medications are not the easy way out,” Dr. Velazquez says. “This is a chronic, relapsing medical condition, and because of that, we should treat it how we treat diabetes, high blood pressure, all these other conditions. We’d never hold back medication for individuals coming in with high blood pressure, tell them to work on willpower and withhold drugs they’d qualify for.”
A version of this article first appeared on WebMD.com.
Weight loss advice is everywhere you look on social media, but one trend sweeping TikTok has led to shortages of an important diabetes drug.
Ozempic, a weekly injection that helps boost insulin sensitivity in people with type 2 diabetes, also suppresses appetite, which leads to weight loss. Stories of celebrities using the drug off-label to lose a few pounds have led to an explosion of interest. And now people with diabetes – people whose lives could be saved by the drug – are having trouble finding it.
Kim Kardashian and Elon Musk
In the spring, Kim Kardashian pulled off a dramatic weight loss to fit into Marilyn Monroe’s dress for the Met Gala. Soon rumors began to circulate that she’d used Ozempic to do it. Just this week, new Twitter owner Elon Musk tweeted about his own use of Ozempic and its sibling drug, Wegovy.
Variety dubbed Ozempic “the worst kept secret in Hollywood – especially given that its most enthusiastic users are not prediabetic and do not require the drug.” The rich and famous are spending $1,200 to $1,500 a month to get access.
As so often happens, high-profile use sparked a trend. Videos on TikTok hashtagged #ozempic have amassed more than 275 million views, and #ozempicweightloss has more than 110 million.
This raises concerns about who, exactly, is watching these videos, and what message they’re receiving.
“Forty-two percent of Americans have obesity, and even more have overweight. That’s affecting our younger people and our adolescents,” says Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at the Brigham and Women’s Hospital in Boston. “They’re looking at TikTok and other social media outlets for help.”
A new study shows how damaging this can be: Researchers analyzed 1,000 videos with nutrition, food, and weight-related hashtags, with over 1 billion views combined. They found that nearly all included messages glorifying weight loss and thinness.
At last, an effective weight-loss drug
Ozempic is Danish drug company Novo Nordisk’s brand name for semaglutide, which works by mimicking a naturally occurring hormone known as GLP-1. It travels to your brain and helps you feel full on less food. That leads to weight loss. In one 68-week study, semaglutide helped people lose an average of 15% of their body weight. But it’s not a miracle drug: You still have to change your eating habits and stay physically active.
The FDA approved Ozempic to treat people with type 2 diabetes in 2017. Four years later, Novo Nordisk received the green light for a higher-dose version meant specifically for people with obesity. Wegovy is approved for use only if you have a BMI of at least 27 with one or more weight-related ailments, or a BMI of 30 or more with none.
“These drugs are dominating my practice, because they’re so effective,” says Amanda Velazquez, MD, director of obesity medicine at Cedars-Sinai Medical Center in Los Angeles. The drug is considered safe, “so the majority of patients are good candidates.”
More demand than supply
As word spread about how well Ozempic and Wegovy worked, social media posts helped drive even more people to seek out the drugs. Now demand is outpacing the supply – according to the FDA, starter doses of Ozempic will have limited availability through January.
“In Hollywood, people are losing 10 pounds, getting it for $1,500 a month, and depleting stores for people who have such severe obesity that they have congestive heart failure and diabetes,” Dr. Apovian says. “These are people who are going to die, and you’re taking it away just for cosmetic weight loss. That is deplorable.”
In addition to huge demand, Wegovy also had a disruption in its supply chain. Right now, it isn’t available at all in lower doses, which is helping to spike off-label demand for Ozempic. Novo Nordisk expects to have these problems sorted out by the end of the year, with distribution following soon after.
The price of access
With a list price of $1,350 a month, Wegovy costs as much as many mortgages. And Medicaid, Medicare, and many insurance companies don’t cover it. Although obesity is a disease, the insurance industry treats weight loss as more of a vanity issue – so even if you could find the drug, you might not be able to afford it.
“We’re seeing that roughly half the prescriptions we write aren’t being covered,” Dr. Apovian says. “And for the half that are covered, we have to do prior authorization, which takes days, and it’s laborious.” In some instances, she says, insurance companies withdraw authorization after 3 months if they don’t see enough weight coming off.
It’s not like you can take Wegovy for 3 months, lose some weight, and expect it to stay off, either. The medication requires a real commitment, potentially for life. That’s because once the semaglutide leaves your system, your appetite returns. In one study, people regained two-thirds of the weight they’d lost within a year of stopping.
Many see a double standard in the insurance companies’ refusal to cover a drug that could prevent serious illness or death.
“They’re saying it’s not cost-effective to give the 42% of Americans who have a BMI over 30 Wegovy. Did they say this when statins came out?” Dr. Apovian says. “Why are they doing this with antiobesity agents? It’s the culture. The culture isn’t ready to adopt obesity as the disease that it is.”
Unpleasant side effects
Let’s assume you’re one of the lucky ones – your insurance covers Wegovy, and you can actually find some. You might discover that using it is no walk in the park. Common side effects include gastrointestinal issues like nausea, vomiting, and diarrhea.
“The way we counteract that is to start very slowly at a low dose of these medications,” Dr. Apovian says. “We only go up when the patient doesn’t have nausea or it gets better.”
Elise Davenport was excited to try Wegovy. “I did my online research. I’m the type who’s interested in early adoption, tech gadgets and stuff,” says the 40-year-old technical writer. “I wanted to try it because I’d tried so many other things that failed, or hadn’t worked long-term.”
With a BMI over 30, Ms. Davenport qualified for the drug. She signed up for an online program that guaranteed insurance coverage and started taking it in October 2021. At first, the side effects were mild, just a touch of nausea and diarrhea. And the results were impressive. She found it easy to feel satisfied with smaller portions and lost her cravings for sugar and highly processed foods. The weight fell off, roughly 5 pounds a week.
It turns out, that’s too much, too fast. Dr. Apovian and Dr. Velazquez say their patients lose more like 2 pounds each week, with careful monitoring.
By early December, Ms. Davenport’s side effects were ramping up. Because of shortages in lower dosages, the online program wasn’t able to adjust hers right away. She felt nauseated all the time, bad enough that brushing her teeth made her vomit and she had to force herself to eat. Some weeks, she managed less than 500 calories a day. Her sleep patterns became erratic. And then her depression, which medication had kept under control for years, spiraled.
“I remember sitting on the floor of my bathroom crying, thinking I’d rather carry the extra weight,” she says. “I used to take a lot of enjoyment from food, and I had none of that anymore. It was such a joyless experience at that point.”
Eventually, her dosage was reduced and the symptoms let up, but her primary care doctor encouraged her to stop. By the time she did, in March, she’d lost 55 pounds. So far, she’s gained back about 10.
More than just weight loss
Even though Ms. Davenport’s experience wasn’t a good one, with better monitoring, she’d be willing to try again. For one thing, seeing how easy it was to eat less with medical help helped to undo years of shame.
“Our culture treats obesity like a moral failing. I realized I’d been made to feel that way by doctors and programs – that I wasn’t doing enough,” she says. “This drug made me realize there are legit physiological things going on in my body, things that are often excluded from the conversation.”
Dr. Apovian and Dr. Velazquez say their patients regularly discover similar things.
“Obesity is not a disease of willpower. Medications are not the easy way out,” Dr. Velazquez says. “This is a chronic, relapsing medical condition, and because of that, we should treat it how we treat diabetes, high blood pressure, all these other conditions. We’d never hold back medication for individuals coming in with high blood pressure, tell them to work on willpower and withhold drugs they’d qualify for.”
A version of this article first appeared on WebMD.com.
Weight loss advice is everywhere you look on social media, but one trend sweeping TikTok has led to shortages of an important diabetes drug.
Ozempic, a weekly injection that helps boost insulin sensitivity in people with type 2 diabetes, also suppresses appetite, which leads to weight loss. Stories of celebrities using the drug off-label to lose a few pounds have led to an explosion of interest. And now people with diabetes – people whose lives could be saved by the drug – are having trouble finding it.
Kim Kardashian and Elon Musk
In the spring, Kim Kardashian pulled off a dramatic weight loss to fit into Marilyn Monroe’s dress for the Met Gala. Soon rumors began to circulate that she’d used Ozempic to do it. Just this week, new Twitter owner Elon Musk tweeted about his own use of Ozempic and its sibling drug, Wegovy.
Variety dubbed Ozempic “the worst kept secret in Hollywood – especially given that its most enthusiastic users are not prediabetic and do not require the drug.” The rich and famous are spending $1,200 to $1,500 a month to get access.
As so often happens, high-profile use sparked a trend. Videos on TikTok hashtagged #ozempic have amassed more than 275 million views, and #ozempicweightloss has more than 110 million.
This raises concerns about who, exactly, is watching these videos, and what message they’re receiving.
“Forty-two percent of Americans have obesity, and even more have overweight. That’s affecting our younger people and our adolescents,” says Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at the Brigham and Women’s Hospital in Boston. “They’re looking at TikTok and other social media outlets for help.”
A new study shows how damaging this can be: Researchers analyzed 1,000 videos with nutrition, food, and weight-related hashtags, with over 1 billion views combined. They found that nearly all included messages glorifying weight loss and thinness.
At last, an effective weight-loss drug
Ozempic is Danish drug company Novo Nordisk’s brand name for semaglutide, which works by mimicking a naturally occurring hormone known as GLP-1. It travels to your brain and helps you feel full on less food. That leads to weight loss. In one 68-week study, semaglutide helped people lose an average of 15% of their body weight. But it’s not a miracle drug: You still have to change your eating habits and stay physically active.
The FDA approved Ozempic to treat people with type 2 diabetes in 2017. Four years later, Novo Nordisk received the green light for a higher-dose version meant specifically for people with obesity. Wegovy is approved for use only if you have a BMI of at least 27 with one or more weight-related ailments, or a BMI of 30 or more with none.
“These drugs are dominating my practice, because they’re so effective,” says Amanda Velazquez, MD, director of obesity medicine at Cedars-Sinai Medical Center in Los Angeles. The drug is considered safe, “so the majority of patients are good candidates.”
More demand than supply
As word spread about how well Ozempic and Wegovy worked, social media posts helped drive even more people to seek out the drugs. Now demand is outpacing the supply – according to the FDA, starter doses of Ozempic will have limited availability through January.
“In Hollywood, people are losing 10 pounds, getting it for $1,500 a month, and depleting stores for people who have such severe obesity that they have congestive heart failure and diabetes,” Dr. Apovian says. “These are people who are going to die, and you’re taking it away just for cosmetic weight loss. That is deplorable.”
In addition to huge demand, Wegovy also had a disruption in its supply chain. Right now, it isn’t available at all in lower doses, which is helping to spike off-label demand for Ozempic. Novo Nordisk expects to have these problems sorted out by the end of the year, with distribution following soon after.
The price of access
With a list price of $1,350 a month, Wegovy costs as much as many mortgages. And Medicaid, Medicare, and many insurance companies don’t cover it. Although obesity is a disease, the insurance industry treats weight loss as more of a vanity issue – so even if you could find the drug, you might not be able to afford it.
“We’re seeing that roughly half the prescriptions we write aren’t being covered,” Dr. Apovian says. “And for the half that are covered, we have to do prior authorization, which takes days, and it’s laborious.” In some instances, she says, insurance companies withdraw authorization after 3 months if they don’t see enough weight coming off.
It’s not like you can take Wegovy for 3 months, lose some weight, and expect it to stay off, either. The medication requires a real commitment, potentially for life. That’s because once the semaglutide leaves your system, your appetite returns. In one study, people regained two-thirds of the weight they’d lost within a year of stopping.
Many see a double standard in the insurance companies’ refusal to cover a drug that could prevent serious illness or death.
“They’re saying it’s not cost-effective to give the 42% of Americans who have a BMI over 30 Wegovy. Did they say this when statins came out?” Dr. Apovian says. “Why are they doing this with antiobesity agents? It’s the culture. The culture isn’t ready to adopt obesity as the disease that it is.”
Unpleasant side effects
Let’s assume you’re one of the lucky ones – your insurance covers Wegovy, and you can actually find some. You might discover that using it is no walk in the park. Common side effects include gastrointestinal issues like nausea, vomiting, and diarrhea.
“The way we counteract that is to start very slowly at a low dose of these medications,” Dr. Apovian says. “We only go up when the patient doesn’t have nausea or it gets better.”
Elise Davenport was excited to try Wegovy. “I did my online research. I’m the type who’s interested in early adoption, tech gadgets and stuff,” says the 40-year-old technical writer. “I wanted to try it because I’d tried so many other things that failed, or hadn’t worked long-term.”
With a BMI over 30, Ms. Davenport qualified for the drug. She signed up for an online program that guaranteed insurance coverage and started taking it in October 2021. At first, the side effects were mild, just a touch of nausea and diarrhea. And the results were impressive. She found it easy to feel satisfied with smaller portions and lost her cravings for sugar and highly processed foods. The weight fell off, roughly 5 pounds a week.
It turns out, that’s too much, too fast. Dr. Apovian and Dr. Velazquez say their patients lose more like 2 pounds each week, with careful monitoring.
By early December, Ms. Davenport’s side effects were ramping up. Because of shortages in lower dosages, the online program wasn’t able to adjust hers right away. She felt nauseated all the time, bad enough that brushing her teeth made her vomit and she had to force herself to eat. Some weeks, she managed less than 500 calories a day. Her sleep patterns became erratic. And then her depression, which medication had kept under control for years, spiraled.
“I remember sitting on the floor of my bathroom crying, thinking I’d rather carry the extra weight,” she says. “I used to take a lot of enjoyment from food, and I had none of that anymore. It was such a joyless experience at that point.”
Eventually, her dosage was reduced and the symptoms let up, but her primary care doctor encouraged her to stop. By the time she did, in March, she’d lost 55 pounds. So far, she’s gained back about 10.
More than just weight loss
Even though Ms. Davenport’s experience wasn’t a good one, with better monitoring, she’d be willing to try again. For one thing, seeing how easy it was to eat less with medical help helped to undo years of shame.
“Our culture treats obesity like a moral failing. I realized I’d been made to feel that way by doctors and programs – that I wasn’t doing enough,” she says. “This drug made me realize there are legit physiological things going on in my body, things that are often excluded from the conversation.”
Dr. Apovian and Dr. Velazquez say their patients regularly discover similar things.
“Obesity is not a disease of willpower. Medications are not the easy way out,” Dr. Velazquez says. “This is a chronic, relapsing medical condition, and because of that, we should treat it how we treat diabetes, high blood pressure, all these other conditions. We’d never hold back medication for individuals coming in with high blood pressure, tell them to work on willpower and withhold drugs they’d qualify for.”
A version of this article first appeared on WebMD.com.