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Caring messages to veterans at risk for suicide come in many forms: cards, letters, phone calls, email, and text messages. Each message can have a major impact on the veteran’s mental health and their decision to use health care provided by the US Department of Veterans Affairs (VA). A recent study outlined ways to centralize that impact, ensuring the caring message reaches those who need it most.

The study examined the impact of the VA Veterans Crisis Line (VCL) caring letters intervention among veterans at increased psychiatric risk. It focused on veterans with ≥ 2 Veterans Health Administration (VHA) health service encounters within 24 months prior to VCL contact. The primary outcome was suicide-related events (SRE), including suicide attempts, intentional self-harm, and suicidal self-directed violence. Secondary outcomes included VHA health care use (all-cause inpatient and outpatient, mental health outpatient, mental health inpatient, and emergency department). 

Of 186,514 VCL callers, 8.3% had a psychiatric hospitalization, 4.8% were flagged as high-risk by the REACH VET program, 6.2% had an SRE, and 12.9% met any of these criteria in the year prior to initial VCL contact. There was no association between caring letters and all-cause mortality or SRE, even though caring letters is one of the only interventions to demonstrate a reduction in suicide mortality as a randomized controlled trial.

While reducing suicide has not been the expected result, caring letters have consistently been associated with increased use of outpatient mental health services. The analysis found that veterans with and without indicators of elevated psychiatric risk were using services more. That, the researchers suggest, is more evidence that caring letters might prompt engagement with VHA care, even among veterans not identified as high risk.

Psychiatrist Jerome A. Motto, MD believed long-term supportive but nondemanding contact could reduce a suicidal person’s sense of isolation and enhance feelings of connectedness. His 1976 intervention established a plan to “exert a suicide prevention influence on high-risk persons who decline to enter the health care system.” In Motto’s 5-year follow-up study of 3,006 psychiatric inpatients, half of those who were not following their postdischarge treatment plan received calls or letters expressing interest in their well-being. Suicidal deaths were found to “diverge progressively,” leading Motto to claim the study showed “tentative evidence” that a high-risk population for suicide can be identified and that risk might be reduced through a systematic approach.

Despite those findings, the results of studies on repeated follow-up contact have been mixed. One review outlined how 5 studies showed a statistically significant reduction in suicidal behavior, 4 showed mixed results with trends toward a preventive effect, and 2 studies did not show a preventive effect.

In 2020, the VA launched an intervention for veterans who contacted the VCL. In the first 12 months, CLs were sent to > 100,000 veterans. In feedback interviews, participants described feeling appreciated, cared for, encouraged, and connected. They also said that the CLs helped them engage with community resources and made them more likely to seek VA care. Even veterans who were skeptical of the utility of the caring letters sometimes admitted keeping them.

Finding effective ways to prevent suicide among veterans has been a top priority for the VA. In 2021, then-US Surgeon General Jerome Adams issued a Call to Action that recommended using caring letters when gaps in care may exist, including following crisis line calls.

Caring messages to veterans at risk for suicide come in many forms: cards, letters, phone calls, email, and text messages. Each message can have a major impact on the veteran’s mental health and their decision to use health care provided by the US Department of Veterans Affairs (VA). A recent study outlined ways to centralize that impact, ensuring the caring message reaches those who need it most.

The study examined the impact of the VA Veterans Crisis Line (VCL) caring letters intervention among veterans at increased psychiatric risk. It focused on veterans with ≥ 2 Veterans Health Administration (VHA) health service encounters within 24 months prior to VCL contact. The primary outcome was suicide-related events (SRE), including suicide attempts, intentional self-harm, and suicidal self-directed violence. Secondary outcomes included VHA health care use (all-cause inpatient and outpatient, mental health outpatient, mental health inpatient, and emergency department). 

Of 186,514 VCL callers, 8.3% had a psychiatric hospitalization, 4.8% were flagged as high-risk by the REACH VET program, 6.2% had an SRE, and 12.9% met any of these criteria in the year prior to initial VCL contact. There was no association between caring letters and all-cause mortality or SRE, even though caring letters is one of the only interventions to demonstrate a reduction in suicide mortality as a randomized controlled trial.

While reducing suicide has not been the expected result, caring letters have consistently been associated with increased use of outpatient mental health services. The analysis found that veterans with and without indicators of elevated psychiatric risk were using services more. That, the researchers suggest, is more evidence that caring letters might prompt engagement with VHA care, even among veterans not identified as high risk.

Psychiatrist Jerome A. Motto, MD believed long-term supportive but nondemanding contact could reduce a suicidal person’s sense of isolation and enhance feelings of connectedness. His 1976 intervention established a plan to “exert a suicide prevention influence on high-risk persons who decline to enter the health care system.” In Motto’s 5-year follow-up study of 3,006 psychiatric inpatients, half of those who were not following their postdischarge treatment plan received calls or letters expressing interest in their well-being. Suicidal deaths were found to “diverge progressively,” leading Motto to claim the study showed “tentative evidence” that a high-risk population for suicide can be identified and that risk might be reduced through a systematic approach.

Despite those findings, the results of studies on repeated follow-up contact have been mixed. One review outlined how 5 studies showed a statistically significant reduction in suicidal behavior, 4 showed mixed results with trends toward a preventive effect, and 2 studies did not show a preventive effect.

In 2020, the VA launched an intervention for veterans who contacted the VCL. In the first 12 months, CLs were sent to > 100,000 veterans. In feedback interviews, participants described feeling appreciated, cared for, encouraged, and connected. They also said that the CLs helped them engage with community resources and made them more likely to seek VA care. Even veterans who were skeptical of the utility of the caring letters sometimes admitted keeping them.

Finding effective ways to prevent suicide among veterans has been a top priority for the VA. In 2021, then-US Surgeon General Jerome Adams issued a Call to Action that recommended using caring letters when gaps in care may exist, including following crisis line calls.

Caring messages to veterans at risk for suicide come in many forms: cards, letters, phone calls, email, and text messages. Each message can have a major impact on the veteran’s mental health and their decision to use health care provided by the US Department of Veterans Affairs (VA). A recent study outlined ways to centralize that impact, ensuring the caring message reaches those who need it most.

The study examined the impact of the VA Veterans Crisis Line (VCL) caring letters intervention among veterans at increased psychiatric risk. It focused on veterans with ≥ 2 Veterans Health Administration (VHA) health service encounters within 24 months prior to VCL contact. The primary outcome was suicide-related events (SRE), including suicide attempts, intentional self-harm, and suicidal self-directed violence. Secondary outcomes included VHA health care use (all-cause inpatient and outpatient, mental health outpatient, mental health inpatient, and emergency department). 

Of 186,514 VCL callers, 8.3% had a psychiatric hospitalization, 4.8% were flagged as high-risk by the REACH VET program, 6.2% had an SRE, and 12.9% met any of these criteria in the year prior to initial VCL contact. There was no association between caring letters and all-cause mortality or SRE, even though caring letters is one of the only interventions to demonstrate a reduction in suicide mortality as a randomized controlled trial.

While reducing suicide has not been the expected result, caring letters have consistently been associated with increased use of outpatient mental health services. The analysis found that veterans with and without indicators of elevated psychiatric risk were using services more. That, the researchers suggest, is more evidence that caring letters might prompt engagement with VHA care, even among veterans not identified as high risk.

Psychiatrist Jerome A. Motto, MD believed long-term supportive but nondemanding contact could reduce a suicidal person’s sense of isolation and enhance feelings of connectedness. His 1976 intervention established a plan to “exert a suicide prevention influence on high-risk persons who decline to enter the health care system.” In Motto’s 5-year follow-up study of 3,006 psychiatric inpatients, half of those who were not following their postdischarge treatment plan received calls or letters expressing interest in their well-being. Suicidal deaths were found to “diverge progressively,” leading Motto to claim the study showed “tentative evidence” that a high-risk population for suicide can be identified and that risk might be reduced through a systematic approach.

Despite those findings, the results of studies on repeated follow-up contact have been mixed. One review outlined how 5 studies showed a statistically significant reduction in suicidal behavior, 4 showed mixed results with trends toward a preventive effect, and 2 studies did not show a preventive effect.

In 2020, the VA launched an intervention for veterans who contacted the VCL. In the first 12 months, CLs were sent to > 100,000 veterans. In feedback interviews, participants described feeling appreciated, cared for, encouraged, and connected. They also said that the CLs helped them engage with community resources and made them more likely to seek VA care. Even veterans who were skeptical of the utility of the caring letters sometimes admitted keeping them.

Finding effective ways to prevent suicide among veterans has been a top priority for the VA. In 2021, then-US Surgeon General Jerome Adams issued a Call to Action that recommended using caring letters when gaps in care may exist, including following crisis line calls.

Traumatic and environmental exposures during military service may put women veterans at risk for early menopause, a recent longitudinal analysis of data from 668 women in the Gulf War Era Cohort Study found.

The study examined associations between possible early menopause (aged < 45 years) and participants’ Gulf War deployment, military environmental exposures (MEEs), Gulf War Illness, military sexual trauma (MST) and posttraumatic stress disorder (PTSD). 

Of 384 Gulf War–deployed veterans, 63% reported MEEs and 26% reported MST during deployment. More than half (57%) of study participants (both Gulf War veterans and nondeployed veterans) met criteria for Gulf War Illness, and 23% met criteria for probable PTSD. 

At follow-up, 15% of the women had possible early menopause—higher than population estimates for early menopause in the US, which range from 5% to 10%.

Gulf War deployment, Gulf War–related environmental exposures, and MST during deployment were not significantly associated with early menopause. However, both Gulf War Illness (odds ratio [OR], 1.83; 95% CI, 1.14 to 2.95) and probable PTSD (OR, 2.45; 95% CI, 1.54 to 3.90) were strongly associated with early menopause. Women with probable PTSD at baseline had more than double the odds of possible early menopause.

Previous research suggests that deployment, MEEs, and Gulf War Illness are broadly associated with adverse reproductive health conditions in women veterans. Exposure to persistent organic pollutants and combustion byproducts (eg, from industrial processes and burn pits) have been linked to ovarian dysfunction and oocyte destruction presumed to contribute to accelerated ovarian aging.

The average age for menopause in the US is 52 years. About 5% of women go through early menopause naturally. Early and premature (< 40 years) menopause may also result from a medical or surgical cause, such as a hysterectomy. Regardless the cause, early menopause can have a profound impact on a woman’s physical, emotional, and mental health. It is associated with premature mortality, poor bone health, sexual dysfunction, a 50% increased risk of cardiovascular disease, and 2-fold increased odds of depression.

“Sometimes we talk about menopause symptoms thinking that they're just sort of 1 brief point in time, but we're also talking about things that may affect women's health and functioning for a third or half of a lifespan,” Carolyn Gibson, PhD, MPH, said at the 2024 Spotlight on Women's Health Cyberseminar Series.

Gibson, a staff psychologist at the San Francisco Veterans Affairs (VA) Women’s Mental Health Program and lead author on the recent early-menopause study, pointed to some of the chronic physical health issues that might develop, such as cardiovascular disease, but also the psychological effects.

“It's just important,” she said during the Cyberseminar Series. “To think about the number of things that women in midlife tend to be juggling and managing, all of which may turn up the volume on symptom experience, effect of vulnerability to health and mental health challenges during this period.”

The findings of the study have clinical implications. Midlife women veterans (aged 45 to 64 years) are the largest group of women veterans enrolled in VA health care. Early menopause brings additional age-related care considerations. The authors advise prioritizing support for routine screening for menopause status and symptoms as well as gender-sensitive training, resources, and staffing to provide comprehensive, trauma-informed, evidence-based menopause care for women at any age.

Traumatic and environmental exposures during military service may put women veterans at risk for early menopause, a recent longitudinal analysis of data from 668 women in the Gulf War Era Cohort Study found.

The study examined associations between possible early menopause (aged < 45 years) and participants’ Gulf War deployment, military environmental exposures (MEEs), Gulf War Illness, military sexual trauma (MST) and posttraumatic stress disorder (PTSD). 

Of 384 Gulf War–deployed veterans, 63% reported MEEs and 26% reported MST during deployment. More than half (57%) of study participants (both Gulf War veterans and nondeployed veterans) met criteria for Gulf War Illness, and 23% met criteria for probable PTSD. 

At follow-up, 15% of the women had possible early menopause—higher than population estimates for early menopause in the US, which range from 5% to 10%.

Gulf War deployment, Gulf War–related environmental exposures, and MST during deployment were not significantly associated with early menopause. However, both Gulf War Illness (odds ratio [OR], 1.83; 95% CI, 1.14 to 2.95) and probable PTSD (OR, 2.45; 95% CI, 1.54 to 3.90) were strongly associated with early menopause. Women with probable PTSD at baseline had more than double the odds of possible early menopause.

Previous research suggests that deployment, MEEs, and Gulf War Illness are broadly associated with adverse reproductive health conditions in women veterans. Exposure to persistent organic pollutants and combustion byproducts (eg, from industrial processes and burn pits) have been linked to ovarian dysfunction and oocyte destruction presumed to contribute to accelerated ovarian aging.

The average age for menopause in the US is 52 years. About 5% of women go through early menopause naturally. Early and premature (< 40 years) menopause may also result from a medical or surgical cause, such as a hysterectomy. Regardless the cause, early menopause can have a profound impact on a woman’s physical, emotional, and mental health. It is associated with premature mortality, poor bone health, sexual dysfunction, a 50% increased risk of cardiovascular disease, and 2-fold increased odds of depression.

“Sometimes we talk about menopause symptoms thinking that they're just sort of 1 brief point in time, but we're also talking about things that may affect women's health and functioning for a third or half of a lifespan,” Carolyn Gibson, PhD, MPH, said at the 2024 Spotlight on Women's Health Cyberseminar Series.

Gibson, a staff psychologist at the San Francisco Veterans Affairs (VA) Women’s Mental Health Program and lead author on the recent early-menopause study, pointed to some of the chronic physical health issues that might develop, such as cardiovascular disease, but also the psychological effects.

“It's just important,” she said during the Cyberseminar Series. “To think about the number of things that women in midlife tend to be juggling and managing, all of which may turn up the volume on symptom experience, effect of vulnerability to health and mental health challenges during this period.”

The findings of the study have clinical implications. Midlife women veterans (aged 45 to 64 years) are the largest group of women veterans enrolled in VA health care. Early menopause brings additional age-related care considerations. The authors advise prioritizing support for routine screening for menopause status and symptoms as well as gender-sensitive training, resources, and staffing to provide comprehensive, trauma-informed, evidence-based menopause care for women at any age.

Traumatic and environmental exposures during military service may put women veterans at risk for early menopause, a recent longitudinal analysis of data from 668 women in the Gulf War Era Cohort Study found.

The study examined associations between possible early menopause (aged < 45 years) and participants’ Gulf War deployment, military environmental exposures (MEEs), Gulf War Illness, military sexual trauma (MST) and posttraumatic stress disorder (PTSD). 

Of 384 Gulf War–deployed veterans, 63% reported MEEs and 26% reported MST during deployment. More than half (57%) of study participants (both Gulf War veterans and nondeployed veterans) met criteria for Gulf War Illness, and 23% met criteria for probable PTSD. 

At follow-up, 15% of the women had possible early menopause—higher than population estimates for early menopause in the US, which range from 5% to 10%.

Gulf War deployment, Gulf War–related environmental exposures, and MST during deployment were not significantly associated with early menopause. However, both Gulf War Illness (odds ratio [OR], 1.83; 95% CI, 1.14 to 2.95) and probable PTSD (OR, 2.45; 95% CI, 1.54 to 3.90) were strongly associated with early menopause. Women with probable PTSD at baseline had more than double the odds of possible early menopause.

Previous research suggests that deployment, MEEs, and Gulf War Illness are broadly associated with adverse reproductive health conditions in women veterans. Exposure to persistent organic pollutants and combustion byproducts (eg, from industrial processes and burn pits) have been linked to ovarian dysfunction and oocyte destruction presumed to contribute to accelerated ovarian aging.

The average age for menopause in the US is 52 years. About 5% of women go through early menopause naturally. Early and premature (< 40 years) menopause may also result from a medical or surgical cause, such as a hysterectomy. Regardless the cause, early menopause can have a profound impact on a woman’s physical, emotional, and mental health. It is associated with premature mortality, poor bone health, sexual dysfunction, a 50% increased risk of cardiovascular disease, and 2-fold increased odds of depression.

“Sometimes we talk about menopause symptoms thinking that they're just sort of 1 brief point in time, but we're also talking about things that may affect women's health and functioning for a third or half of a lifespan,” Carolyn Gibson, PhD, MPH, said at the 2024 Spotlight on Women's Health Cyberseminar Series.

Gibson, a staff psychologist at the San Francisco Veterans Affairs (VA) Women’s Mental Health Program and lead author on the recent early-menopause study, pointed to some of the chronic physical health issues that might develop, such as cardiovascular disease, but also the psychological effects.

“It's just important,” she said during the Cyberseminar Series. “To think about the number of things that women in midlife tend to be juggling and managing, all of which may turn up the volume on symptom experience, effect of vulnerability to health and mental health challenges during this period.”

The findings of the study have clinical implications. Midlife women veterans (aged 45 to 64 years) are the largest group of women veterans enrolled in VA health care. Early menopause brings additional age-related care considerations. The authors advise prioritizing support for routine screening for menopause status and symptoms as well as gender-sensitive training, resources, and staffing to provide comprehensive, trauma-informed, evidence-based menopause care for women at any age.

A bid by GlaxoSmithKline (GSK) to bring its multiple myeloma drug belantamab mafodotin (Blenrep) back to the market hit a stumbling block during an FDA panel meeting held on July 17.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 5-3 against belantamab in combination with bortezomib and dexamethasone and 7-1 against belantamab in combination with pomalidamide and dexamethasone on the specific questions of whether the benefits of each treatment regimen at the proposed doses outweigh the risks for patients with relapsed or refractory disease after at least one prior line of therapy.

ODAC members voting no cited concerns about the lack of exploration of optimal dosing, as well as high rates of ocular toxicity and a lack of diversity among trial participants.

“This was a challenging decision because the efficacy data were strong, but the toxicity data were also very strong,” said Neil Vasan, MD, PhD, of New York University Langone Health in New York City.

Regarding optimal dosing, Vasan, who voted no on both questions, cited “a missed opportunity over the course of many years during the development of this drug to explore these different dosages,” but he also noted that “the building blocks are here to explore this question in the future.”

Belantamab, an antibody-drug conjugate targeting B-cell maturation antigen, was granted accelerated approval as a late-line therapy for relapsed or refractory multiple myeloma in August 2020 based on findings from the DREAMM-2 trial. However, GSK voluntarily withdrew the drug from the US market in 2023 after the confirmatory DREAMM-3 trial did not meet its primary endpoint of improved progression-free survival (PFS).

The company continued to explore belantamab in combination with other agents and in earlier lines of therapy. Based on findings from the DREAMM-7 and DREAMM-8 trials, which both showed improved PFS vs standard-of-care triplet therapies, the company submitted a new Biologics License Application in November 2024 seeking approval of the belantamab-based regimens.

Findings from DREAMM-7 and DREAMM-8 were reported at the 2025 American Society of Clinical Oncology conference in Chicago in June.

Both studies met their primary PFS endpoints, but the FDA expressed concerns about adverse events, dosing, and the relevance of the data for US patients and therefore sought input from ODAC members on the proposed dosages of 2.5 mg/kg every 3 weeks for the belantamab plus bortezomib and dexamethasone combination and 2.5 mg/kg in cycle 1, followed by 1.0 mg/kg every 4 weeks for the belantamab plus pomalidamide and dexamethasone combination.

Although GSK and several patients with multiple myeloma touted life-saving benefits of belantamab and argued that ocular toxicity associated with treatment is manageable and transient, most — but not all — ODAC members were unconvinced, at least as to the immediate questions regarding the benefit-risk profile.

“This is probably one of the most difficult votes I’ve done as a member of this committee,” said Grzegorz S. Nowakowski, MD, of the Mayo Clinic, Rochester, Minnesota, who voted yes on belantamab plus bortezomib and dexamethasone.

Nowakowski noted mistakes made from a regulatory perspective, including a lack of appropriate US patient representation in the trials and attention to dose optimization, but ultimately said that, as a practicing hematologist, he couldn’t ignore the drug’s clear activity, including a possible overall survival benefit, and the potential for mitigating toxicity with careful follow-up and dose reductions.

John DeFlice, MD, of Cedars-Sinai Samuel Oschin Cancer Center in Los Angeles — a multiple myeloma survivor and patient representative on the committee — voted yes on both questions, noting that, based on the testimony of patients and the clinical experience of the investigators, belantamab is “an amazing drug for an incurable disease.”

“I think [these] are the wrong issues to be evaluated,” DeFlice said of the specific questions posed by the FDA at the hearing.

The FDA considers the recommendations of its advisory panels in making final approval decisions but is not bound by them.

A version of this article first appeared on Medscape.com.

A bid by GlaxoSmithKline (GSK) to bring its multiple myeloma drug belantamab mafodotin (Blenrep) back to the market hit a stumbling block during an FDA panel meeting held on July 17.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 5-3 against belantamab in combination with bortezomib and dexamethasone and 7-1 against belantamab in combination with pomalidamide and dexamethasone on the specific questions of whether the benefits of each treatment regimen at the proposed doses outweigh the risks for patients with relapsed or refractory disease after at least one prior line of therapy.

ODAC members voting no cited concerns about the lack of exploration of optimal dosing, as well as high rates of ocular toxicity and a lack of diversity among trial participants.

“This was a challenging decision because the efficacy data were strong, but the toxicity data were also very strong,” said Neil Vasan, MD, PhD, of New York University Langone Health in New York City.

Regarding optimal dosing, Vasan, who voted no on both questions, cited “a missed opportunity over the course of many years during the development of this drug to explore these different dosages,” but he also noted that “the building blocks are here to explore this question in the future.”

Belantamab, an antibody-drug conjugate targeting B-cell maturation antigen, was granted accelerated approval as a late-line therapy for relapsed or refractory multiple myeloma in August 2020 based on findings from the DREAMM-2 trial. However, GSK voluntarily withdrew the drug from the US market in 2023 after the confirmatory DREAMM-3 trial did not meet its primary endpoint of improved progression-free survival (PFS).

The company continued to explore belantamab in combination with other agents and in earlier lines of therapy. Based on findings from the DREAMM-7 and DREAMM-8 trials, which both showed improved PFS vs standard-of-care triplet therapies, the company submitted a new Biologics License Application in November 2024 seeking approval of the belantamab-based regimens.

Findings from DREAMM-7 and DREAMM-8 were reported at the 2025 American Society of Clinical Oncology conference in Chicago in June.

Both studies met their primary PFS endpoints, but the FDA expressed concerns about adverse events, dosing, and the relevance of the data for US patients and therefore sought input from ODAC members on the proposed dosages of 2.5 mg/kg every 3 weeks for the belantamab plus bortezomib and dexamethasone combination and 2.5 mg/kg in cycle 1, followed by 1.0 mg/kg every 4 weeks for the belantamab plus pomalidamide and dexamethasone combination.

Although GSK and several patients with multiple myeloma touted life-saving benefits of belantamab and argued that ocular toxicity associated with treatment is manageable and transient, most — but not all — ODAC members were unconvinced, at least as to the immediate questions regarding the benefit-risk profile.

“This is probably one of the most difficult votes I’ve done as a member of this committee,” said Grzegorz S. Nowakowski, MD, of the Mayo Clinic, Rochester, Minnesota, who voted yes on belantamab plus bortezomib and dexamethasone.

Nowakowski noted mistakes made from a regulatory perspective, including a lack of appropriate US patient representation in the trials and attention to dose optimization, but ultimately said that, as a practicing hematologist, he couldn’t ignore the drug’s clear activity, including a possible overall survival benefit, and the potential for mitigating toxicity with careful follow-up and dose reductions.

John DeFlice, MD, of Cedars-Sinai Samuel Oschin Cancer Center in Los Angeles — a multiple myeloma survivor and patient representative on the committee — voted yes on both questions, noting that, based on the testimony of patients and the clinical experience of the investigators, belantamab is “an amazing drug for an incurable disease.”

“I think [these] are the wrong issues to be evaluated,” DeFlice said of the specific questions posed by the FDA at the hearing.

The FDA considers the recommendations of its advisory panels in making final approval decisions but is not bound by them.

A version of this article first appeared on Medscape.com.

A bid by GlaxoSmithKline (GSK) to bring its multiple myeloma drug belantamab mafodotin (Blenrep) back to the market hit a stumbling block during an FDA panel meeting held on July 17.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 5-3 against belantamab in combination with bortezomib and dexamethasone and 7-1 against belantamab in combination with pomalidamide and dexamethasone on the specific questions of whether the benefits of each treatment regimen at the proposed doses outweigh the risks for patients with relapsed or refractory disease after at least one prior line of therapy.

ODAC members voting no cited concerns about the lack of exploration of optimal dosing, as well as high rates of ocular toxicity and a lack of diversity among trial participants.

“This was a challenging decision because the efficacy data were strong, but the toxicity data were also very strong,” said Neil Vasan, MD, PhD, of New York University Langone Health in New York City.

Regarding optimal dosing, Vasan, who voted no on both questions, cited “a missed opportunity over the course of many years during the development of this drug to explore these different dosages,” but he also noted that “the building blocks are here to explore this question in the future.”

Belantamab, an antibody-drug conjugate targeting B-cell maturation antigen, was granted accelerated approval as a late-line therapy for relapsed or refractory multiple myeloma in August 2020 based on findings from the DREAMM-2 trial. However, GSK voluntarily withdrew the drug from the US market in 2023 after the confirmatory DREAMM-3 trial did not meet its primary endpoint of improved progression-free survival (PFS).

The company continued to explore belantamab in combination with other agents and in earlier lines of therapy. Based on findings from the DREAMM-7 and DREAMM-8 trials, which both showed improved PFS vs standard-of-care triplet therapies, the company submitted a new Biologics License Application in November 2024 seeking approval of the belantamab-based regimens.

Findings from DREAMM-7 and DREAMM-8 were reported at the 2025 American Society of Clinical Oncology conference in Chicago in June.

Both studies met their primary PFS endpoints, but the FDA expressed concerns about adverse events, dosing, and the relevance of the data for US patients and therefore sought input from ODAC members on the proposed dosages of 2.5 mg/kg every 3 weeks for the belantamab plus bortezomib and dexamethasone combination and 2.5 mg/kg in cycle 1, followed by 1.0 mg/kg every 4 weeks for the belantamab plus pomalidamide and dexamethasone combination.

Although GSK and several patients with multiple myeloma touted life-saving benefits of belantamab and argued that ocular toxicity associated with treatment is manageable and transient, most — but not all — ODAC members were unconvinced, at least as to the immediate questions regarding the benefit-risk profile.

“This is probably one of the most difficult votes I’ve done as a member of this committee,” said Grzegorz S. Nowakowski, MD, of the Mayo Clinic, Rochester, Minnesota, who voted yes on belantamab plus bortezomib and dexamethasone.

Nowakowski noted mistakes made from a regulatory perspective, including a lack of appropriate US patient representation in the trials and attention to dose optimization, but ultimately said that, as a practicing hematologist, he couldn’t ignore the drug’s clear activity, including a possible overall survival benefit, and the potential for mitigating toxicity with careful follow-up and dose reductions.

John DeFlice, MD, of Cedars-Sinai Samuel Oschin Cancer Center in Los Angeles — a multiple myeloma survivor and patient representative on the committee — voted yes on both questions, noting that, based on the testimony of patients and the clinical experience of the investigators, belantamab is “an amazing drug for an incurable disease.”

“I think [these] are the wrong issues to be evaluated,” DeFlice said of the specific questions posed by the FDA at the hearing.

The FDA considers the recommendations of its advisory panels in making final approval decisions but is not bound by them.

A version of this article first appeared on Medscape.com.

Pseudofolliculitis barbae (PFB), also known as razor bumps, is a common inflammatory condition characterized by papules and pustules that typically appear in the beard and cheek regions. It occurs when shaved hair regrows and penetrates the skin, leading to irritation and inflammation. While anyone who shaves can develop PFB, it is more prevalent and severe in individuals with naturally tightly coiled, coarse-textured hair.^1,2 PFB is common in individuals who shave frequently due to personal choice or profession, such as members of the US military^3,4 and firefighters, who are required to remain clean shaven for safety (eg, ensuring proper fit of a respirator mask).⁵ Early diagnosis and treatment of PFB are essential to prevent long-term complications such as scarring or hyperpigmentation, which may be more severe in those with darker skin tones.

Epidemiology

PFB is most common in Black men, affecting 45% to 83% of men of African ancestry.^1,2 This condition also can affect individuals of various ethnicities with coarse or curly hair. The spiral shape of the hair increases the likelihood that it will regrow into the skin after shaving.⁶ Women with hirsutism who shave also can develop PFB.

Key Clinical Features

The papules and pustules seen in PFB may be flesh colored, erythematous, hyperpigmented, brown, or violaceous. Erythema may be less pronounced in darker vs lighter skin tones. Persistent and severe postinflammatory hyperpigmentation may occur, and hypertrophic or keloidal scars may develop in affected areas. Dermoscopy may reveal extrafollicular hair penetration as well as follicular or perifollicular pustules accompanied by hyperkeratosis.

Worth Noting

The most effective management for PFB is to discontinue shaving.¹ If shaving is desired or necessary, it is recommended that patients apply lukewarm water to the affected area followed by a generous amount of shaving foam or gel to create a protective antifriction layer that allows the razor to glide more smoothly over the skin and reduces subsequent irritation.² Using the right razor technology also may help alleviate symptoms. Research has shown that multiblade razors used in conjunction with preshave hair hydration and postshave moisturization do not worsen PFB.² A recent study found that multiblade razor technology paired with use of a shave foam or gel actually improved skin appearance in patients with PFB.⁷

It is important to direct patients to shave in the direction of hair growth; however, this may not be possible for individuals with curly or coarse hair, as the hair may grow in many directions.^8,9 Patients also should avoid pulling the skin taut while shaving, as doing so allows the hair to be clipped below the surface, where it can repenetrate the skin and cause further irritation. As an alternative to shaving with a razor, patients can use hair clippers to trim beard hair, which leaves behind stubble and interrupts the cycle of retracted hairs under the skin. Nd:YAG laser therapy has demonstrated efficacy in reduction of PFB papules and pustules.^9-12 Greater mean improvement in inflammatory papules and reduction in hair density was noted in participants who received Nd:YAG laser plus eflornithine compared with those who received the laser or eflornithine alone.¹¹ Patients should not pluck or dig into the skin to remove any ingrown hairs. If a tweezer is used, the patient should gently lift the tip of the ingrown hair with the tweezer to dislodge it from the skin and prevent plucking out the hair completely.

To help manage inflammation after shaving, topical treatments such as benzoyl peroxide 5%/clindamycin 1% gel can be used.^3,13 A low-potency steroid such as topical hydrocortisone 2.5% applied once or twice daily for up to 2 to 3 days may be helpful.^1,14 Adjunctive treatments including keratolytics (eg, topical retinoids, hydroxy acids) reduce perifollicular hyperkeratosis.^14,15 Agents containing alpha hydroxy acids (eg, glycolic acid) also can decrease the curvature of the hair itself by reducing the sulfhydryl bonds.⁶ If secondary bacterial infections occur, oral antibiotics (eg, doxycycline) may be necessary.

Health Disparity Highlight

Individuals with darker skin tones are at higher risk for PFB and associated complications. Limited access to dermatology services may further exacerbate these challenges. Individuals with PFB may not seek medical treatment until the condition becomes severe. Clinicians also may underestimate the severity of PFB—particularly in those with darker skin tones—based on erythema alone because it may be less pronounced in darker vs lighter skin tones.¹⁶

While permanent hair reduction with laser therapy is a treatment option for PFB, it may be inaccessible to some patients because it can be expensive and is coded as a cosmetic procedure. Additionally, patients may not have access to specialists who are experienced in performing the procedure in those with darker skin tones.⁹ Some patients also may not want to permanently reduce the amount of hair that grows in the beard area for personal or religious reasons.¹⁷

Pseudofolliculitis barbae also has been linked to professional disparities. One study found that members of the US Air Force who had medical shaving waivers experienced longer times to promotion than those with no waiver.¹⁸ Delays in promotion may be linked to perceptions of unprofessionalism, exclusion from high-profile duties, and concerns about career progression. While this delay was similar for individuals of all races, the majority of those in the waiver group were Black/African American. In 2021, 4 Black firefighters with PFB were unsuccessful in their bid to get a medical accommodation regarding a New York City Fire Department policy requiring them to be clean shaven where the oxygen mask seals against the skin.⁵ More research is needed on mask safety and efficiency relative to the length of facial hair. Accommodations or tailored masks for facial hair conditions also are necessary so individuals with PFB can meet job requirements while managing their condition.

Pseudofolliculitis barbae (PFB), also known as razor bumps, is a common inflammatory condition characterized by papules and pustules that typically appear in the beard and cheek regions. It occurs when shaved hair regrows and penetrates the skin, leading to irritation and inflammation. While anyone who shaves can develop PFB, it is more prevalent and severe in individuals with naturally tightly coiled, coarse-textured hair.^1,2 PFB is common in individuals who shave frequently due to personal choice or profession, such as members of the US military^3,4 and firefighters, who are required to remain clean shaven for safety (eg, ensuring proper fit of a respirator mask).⁵ Early diagnosis and treatment of PFB are essential to prevent long-term complications such as scarring or hyperpigmentation, which may be more severe in those with darker skin tones.

Epidemiology

PFB is most common in Black men, affecting 45% to 83% of men of African ancestry.^1,2 This condition also can affect individuals of various ethnicities with coarse or curly hair. The spiral shape of the hair increases the likelihood that it will regrow into the skin after shaving.⁶ Women with hirsutism who shave also can develop PFB.

Key Clinical Features

The papules and pustules seen in PFB may be flesh colored, erythematous, hyperpigmented, brown, or violaceous. Erythema may be less pronounced in darker vs lighter skin tones. Persistent and severe postinflammatory hyperpigmentation may occur, and hypertrophic or keloidal scars may develop in affected areas. Dermoscopy may reveal extrafollicular hair penetration as well as follicular or perifollicular pustules accompanied by hyperkeratosis.

Worth Noting

The most effective management for PFB is to discontinue shaving.¹ If shaving is desired or necessary, it is recommended that patients apply lukewarm water to the affected area followed by a generous amount of shaving foam or gel to create a protective antifriction layer that allows the razor to glide more smoothly over the skin and reduces subsequent irritation.² Using the right razor technology also may help alleviate symptoms. Research has shown that multiblade razors used in conjunction with preshave hair hydration and postshave moisturization do not worsen PFB.² A recent study found that multiblade razor technology paired with use of a shave foam or gel actually improved skin appearance in patients with PFB.⁷

It is important to direct patients to shave in the direction of hair growth; however, this may not be possible for individuals with curly or coarse hair, as the hair may grow in many directions.^8,9 Patients also should avoid pulling the skin taut while shaving, as doing so allows the hair to be clipped below the surface, where it can repenetrate the skin and cause further irritation. As an alternative to shaving with a razor, patients can use hair clippers to trim beard hair, which leaves behind stubble and interrupts the cycle of retracted hairs under the skin. Nd:YAG laser therapy has demonstrated efficacy in reduction of PFB papules and pustules.^9-12 Greater mean improvement in inflammatory papules and reduction in hair density was noted in participants who received Nd:YAG laser plus eflornithine compared with those who received the laser or eflornithine alone.¹¹ Patients should not pluck or dig into the skin to remove any ingrown hairs. If a tweezer is used, the patient should gently lift the tip of the ingrown hair with the tweezer to dislodge it from the skin and prevent plucking out the hair completely.

To help manage inflammation after shaving, topical treatments such as benzoyl peroxide 5%/clindamycin 1% gel can be used.^3,13 A low-potency steroid such as topical hydrocortisone 2.5% applied once or twice daily for up to 2 to 3 days may be helpful.^1,14 Adjunctive treatments including keratolytics (eg, topical retinoids, hydroxy acids) reduce perifollicular hyperkeratosis.^14,15 Agents containing alpha hydroxy acids (eg, glycolic acid) also can decrease the curvature of the hair itself by reducing the sulfhydryl bonds.⁶ If secondary bacterial infections occur, oral antibiotics (eg, doxycycline) may be necessary.

Health Disparity Highlight

Individuals with darker skin tones are at higher risk for PFB and associated complications. Limited access to dermatology services may further exacerbate these challenges. Individuals with PFB may not seek medical treatment until the condition becomes severe. Clinicians also may underestimate the severity of PFB—particularly in those with darker skin tones—based on erythema alone because it may be less pronounced in darker vs lighter skin tones.¹⁶

While permanent hair reduction with laser therapy is a treatment option for PFB, it may be inaccessible to some patients because it can be expensive and is coded as a cosmetic procedure. Additionally, patients may not have access to specialists who are experienced in performing the procedure in those with darker skin tones.⁹ Some patients also may not want to permanently reduce the amount of hair that grows in the beard area for personal or religious reasons.¹⁷

Pseudofolliculitis barbae also has been linked to professional disparities. One study found that members of the US Air Force who had medical shaving waivers experienced longer times to promotion than those with no waiver.¹⁸ Delays in promotion may be linked to perceptions of unprofessionalism, exclusion from high-profile duties, and concerns about career progression. While this delay was similar for individuals of all races, the majority of those in the waiver group were Black/African American. In 2021, 4 Black firefighters with PFB were unsuccessful in their bid to get a medical accommodation regarding a New York City Fire Department policy requiring them to be clean shaven where the oxygen mask seals against the skin.⁵ More research is needed on mask safety and efficiency relative to the length of facial hair. Accommodations or tailored masks for facial hair conditions also are necessary so individuals with PFB can meet job requirements while managing their condition.

Pseudofolliculitis barbae (PFB), also known as razor bumps, is a common inflammatory condition characterized by papules and pustules that typically appear in the beard and cheek regions. It occurs when shaved hair regrows and penetrates the skin, leading to irritation and inflammation. While anyone who shaves can develop PFB, it is more prevalent and severe in individuals with naturally tightly coiled, coarse-textured hair.^1,2 PFB is common in individuals who shave frequently due to personal choice or profession, such as members of the US military^3,4 and firefighters, who are required to remain clean shaven for safety (eg, ensuring proper fit of a respirator mask).⁵ Early diagnosis and treatment of PFB are essential to prevent long-term complications such as scarring or hyperpigmentation, which may be more severe in those with darker skin tones.

Epidemiology

PFB is most common in Black men, affecting 45% to 83% of men of African ancestry.^1,2 This condition also can affect individuals of various ethnicities with coarse or curly hair. The spiral shape of the hair increases the likelihood that it will regrow into the skin after shaving.⁶ Women with hirsutism who shave also can develop PFB.

Key Clinical Features

The papules and pustules seen in PFB may be flesh colored, erythematous, hyperpigmented, brown, or violaceous. Erythema may be less pronounced in darker vs lighter skin tones. Persistent and severe postinflammatory hyperpigmentation may occur, and hypertrophic or keloidal scars may develop in affected areas. Dermoscopy may reveal extrafollicular hair penetration as well as follicular or perifollicular pustules accompanied by hyperkeratosis.

Worth Noting

The most effective management for PFB is to discontinue shaving.¹ If shaving is desired or necessary, it is recommended that patients apply lukewarm water to the affected area followed by a generous amount of shaving foam or gel to create a protective antifriction layer that allows the razor to glide more smoothly over the skin and reduces subsequent irritation.² Using the right razor technology also may help alleviate symptoms. Research has shown that multiblade razors used in conjunction with preshave hair hydration and postshave moisturization do not worsen PFB.² A recent study found that multiblade razor technology paired with use of a shave foam or gel actually improved skin appearance in patients with PFB.⁷

It is important to direct patients to shave in the direction of hair growth; however, this may not be possible for individuals with curly or coarse hair, as the hair may grow in many directions.^8,9 Patients also should avoid pulling the skin taut while shaving, as doing so allows the hair to be clipped below the surface, where it can repenetrate the skin and cause further irritation. As an alternative to shaving with a razor, patients can use hair clippers to trim beard hair, which leaves behind stubble and interrupts the cycle of retracted hairs under the skin. Nd:YAG laser therapy has demonstrated efficacy in reduction of PFB papules and pustules.^9-12 Greater mean improvement in inflammatory papules and reduction in hair density was noted in participants who received Nd:YAG laser plus eflornithine compared with those who received the laser or eflornithine alone.¹¹ Patients should not pluck or dig into the skin to remove any ingrown hairs. If a tweezer is used, the patient should gently lift the tip of the ingrown hair with the tweezer to dislodge it from the skin and prevent plucking out the hair completely.

To help manage inflammation after shaving, topical treatments such as benzoyl peroxide 5%/clindamycin 1% gel can be used.^3,13 A low-potency steroid such as topical hydrocortisone 2.5% applied once or twice daily for up to 2 to 3 days may be helpful.^1,14 Adjunctive treatments including keratolytics (eg, topical retinoids, hydroxy acids) reduce perifollicular hyperkeratosis.^14,15 Agents containing alpha hydroxy acids (eg, glycolic acid) also can decrease the curvature of the hair itself by reducing the sulfhydryl bonds.⁶ If secondary bacterial infections occur, oral antibiotics (eg, doxycycline) may be necessary.

Health Disparity Highlight

Individuals with darker skin tones are at higher risk for PFB and associated complications. Limited access to dermatology services may further exacerbate these challenges. Individuals with PFB may not seek medical treatment until the condition becomes severe. Clinicians also may underestimate the severity of PFB—particularly in those with darker skin tones—based on erythema alone because it may be less pronounced in darker vs lighter skin tones.¹⁶

While permanent hair reduction with laser therapy is a treatment option for PFB, it may be inaccessible to some patients because it can be expensive and is coded as a cosmetic procedure. Additionally, patients may not have access to specialists who are experienced in performing the procedure in those with darker skin tones.⁹ Some patients also may not want to permanently reduce the amount of hair that grows in the beard area for personal or religious reasons.¹⁷

Pseudofolliculitis barbae also has been linked to professional disparities. One study found that members of the US Air Force who had medical shaving waivers experienced longer times to promotion than those with no waiver.¹⁸ Delays in promotion may be linked to perceptions of unprofessionalism, exclusion from high-profile duties, and concerns about career progression. While this delay was similar for individuals of all races, the majority of those in the waiver group were Black/African American. In 2021, 4 Black firefighters with PFB were unsuccessful in their bid to get a medical accommodation regarding a New York City Fire Department policy requiring them to be clean shaven where the oxygen mask seals against the skin.⁵ More research is needed on mask safety and efficiency relative to the length of facial hair. Accommodations or tailored masks for facial hair conditions also are necessary so individuals with PFB can meet job requirements while managing their condition.

The US military has revised its grooming standards to remove medical exemptions for male facial hair, a policy change that may put careers at risk for thousands of service members. According to the updated guidelines, all soldiers must be clean-shaven on duty when in uniform or civilian clothes, with temporary exemptions for medical reasons and permanent exemptions for religious accommodations. 

The Army is the latest service branch to update its guidelines about beards: Soldiers with skin conditions will no longer be granted permanent medical waivers that allow them to avoid shaving. The Air Force and Space Force updated their guidance on grooming waivers in January, as did the Marine Corps in March. 

Defense Secretary Pete Hegseth, who ordered the guideline review, focused on grooming and appearance. In a Feb. 7 townhall with troops and department employees, he said, “It starts with the basic stuff, right? It’s grooming standards and uniform standards and training standards, fitness standards, all of that matters.”

Hegseth compared not enforcing grooming standards to the “broken windows” theory of policing: “I’m not saying if you violate grooming standards, you’re a criminal. The analogy is incomplete. But if you violate the small stuff and you allow it to happen, it creates a culture where the big stuff, you’re not held accountable for.”

The policy changes are particularly significant for soldiers who grow beards because they suffer from pseudofolliculitis barbae (PFB), an often-painful genetic condition that causes ingrown hairs. PFB produces flesh-colored or red follicular papules, which can be itchy, tender, and may bleed when shaved. Even if they heal, the lesions may lead to postinflammatory hyperpigmentation, scarring (including keloid scarring), and abscess. 

Although the updated standards affect all service members with beards, they draw ire from those who claim the rules disproportionately affect men of African descent. Up to 60% of Black men have PFB, according to the American Osteopathic College of Dermatology. According to the US Department of Defense (DoD) 2023 Demographics: Profile of the Military Community, service members who self-identify as Black or African American make up 17% of the total DoD military force (N = 2,034,426). Of 1,273,382 active-duty members, 18% are Black. Of 1,038,909 active-duty enlisted members, 20% are Black, and 9% of 234,473 active-duty officers are Black.

“Almost 65% of the US Air Force shaving waivers are held by Black men. And PFB is one of the most common reasons,” DanTasia Welch, MS, told Federal Practitioner. She, along with Richard P. Usatine, MD, and Candrice R. Heath, MD, wrote a recent review of the impact of PFB that was published in Federal Practitioner. 

“It is almost exclusively found in men of African descent,” Usatine said. “That just means if you have a policy that affects people with this condition, you are basically aiming that policy directly at Black men.”

“Pseudofolliculitis barbae, a lot of that just has to do with your shaving technique is what we’ve determined,” Steve Warren, an Army spokesman, told reporters in early July. “A vast majority of minority soldiers, African American soldiers, are within the standards all the time.” 

Usatine disagreed: “[PFB] is genetic, and whether you shave with or against the direction of the hairs, the problem is still there, and you can't just shave it away by ‘shaving correctly.’ They're going after one racial/ethnic group who has this problem, because almost everyone that has the problem is of African descent.”

The most effective management for PFB is to discontinue shaving. Grooming techniques and topical medications can be effective in treating mild-to-moderate cases of PFB, but more severe cases respond best to laser therapy. The Army, Navy, and Marine Corps advise laser therapy as a treatment option, but it has drawbacks. It is expensive and coded as a cosmetic procedure, and patients also may not have access to specialists experienced in performing the procedure in people with darker skin tones. Some patients may not want to permanently reduce the amount of hair that grows in the beard area for personal or religious reasons. 

A survey of Air Force members with 10,383 responses suggested that the men who had medical shaving waivers experienced longer times to promotion than those with no waiver. Most in the waiver group were Black or African American. 

The branches have handled the rule change in different ways. The Air Force, for example, which began tightening its standards on uniform and shaving waivers in January 2025, grants long-term shaving waivers only to airmen or guardians who have severe cases of PFB following consultation with medical practitioners. Air Force Surgeon General Lt. Gen. John DeGoes said in a video that the department’s 2020 (now expired) policy allowing 5-year shaving waivers did not give clinicians enough clarity on diagnosis by not differentiating between PFB and shaving irritation.

“They are 2 different things,” DeGoes said. “Ensuring a standardized approach to managing PFB is essential. And it is crucial that we provide consistent and effective care to our service members, enabling them to meet grooming standards while managing their condition.”

The new grooming policies leave many service members in an uncomfortable quandary: Keep the beard, run the risk of getting kicked out; keep shaving and put your skin and health at risk for complications; or receive laser treatment and have to deal with lack of beard hair after leaving the military.

Simply changing the rules isn’t enough. Candrice Heath, MD, told Federal Practitioner, “You need to always strike a balance. One of those points that’s always raised is about the facial equipment that's needed to protect during times of war.”

Heath called for more research funding to develop equipment, so people can have some facial hair if needed. “There is an opportunity to not just say, hey, this is an issue, but there's an opportunity for innovation here, to really think about it this problem in a different way, so that we are solution-focused.”

The US military has revised its grooming standards to remove medical exemptions for male facial hair, a policy change that may put careers at risk for thousands of service members. According to the updated guidelines, all soldiers must be clean-shaven on duty when in uniform or civilian clothes, with temporary exemptions for medical reasons and permanent exemptions for religious accommodations. 

The Army is the latest service branch to update its guidelines about beards: Soldiers with skin conditions will no longer be granted permanent medical waivers that allow them to avoid shaving. The Air Force and Space Force updated their guidance on grooming waivers in January, as did the Marine Corps in March. 

Defense Secretary Pete Hegseth, who ordered the guideline review, focused on grooming and appearance. In a Feb. 7 townhall with troops and department employees, he said, “It starts with the basic stuff, right? It’s grooming standards and uniform standards and training standards, fitness standards, all of that matters.”

Hegseth compared not enforcing grooming standards to the “broken windows” theory of policing: “I’m not saying if you violate grooming standards, you’re a criminal. The analogy is incomplete. But if you violate the small stuff and you allow it to happen, it creates a culture where the big stuff, you’re not held accountable for.”

The policy changes are particularly significant for soldiers who grow beards because they suffer from pseudofolliculitis barbae (PFB), an often-painful genetic condition that causes ingrown hairs. PFB produces flesh-colored or red follicular papules, which can be itchy, tender, and may bleed when shaved. Even if they heal, the lesions may lead to postinflammatory hyperpigmentation, scarring (including keloid scarring), and abscess.