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Osimertinib (Tagrisso) is approved by the Food and Drug Administration for patients with metastatic EGFR T790M mutation–positive non–small cell lung cancer (NSCLC), the agency announced Nov. 13.
The approval was based on two, single-arm trials, AURA and AURA2, in patients who received osimertinib 80 mg tablets once daily after progressing on systemic therapy, including an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).
First-generation EGFR TKI inhibitors are effective in non–small cell lung cancer (NSCLC), but most tumors develop drug resistance. In nearly two-thirds of cases, the T790 mutation is the culprit.
Osimertinib, a third-generation EGFR TKI, is the first drug to be approved for patients with metastatic EGFR T790M mutation–positive NSCLC. It’s accelerated approval came 3 months ahead of the target approval date of Feb. 6, 2016.
Osimertinib’s approval represents a “milestone for lung cancer patients who urgently needed new treatment options,” and follows one of the fastest development programs, taking a little more than 2.5 years from the first in human clinical trials to approval, according to drug maker AstraZeneca Pharmaceuticals.
Rociletinib, another oral third-generation TKI, is under FDA review for the treatment of previously treated EGFR T790 mutation–positive NSCLC.
The approval of osimertinib was based on tumor response rate and duration of response among 411 patients in the two trials. The objective response rate according to blinded independent review was 57% in AURA and 61% in AURA2 (N Engl J Med. 2015 Apr 30;372[18]:1689-99). Responses were ongoing in most patients in both trials and median duration had not been reached. Ongoing responses ranged from 1.1 months to 5.6 months.
The most common adverse events with osimertinib in the 411 patients were diarrhea (42%), rash (41%), dry skin (31%), nail toxicity (25%), eye disorders (18%), nausea (17%), decreased appetite (16%), and constipation (15%).
The most common grade 3-4 adverse events were pneumonia and pulmonary embolism (2% each).
The full prescribing information for osimertinib is available here.
Under the accelerated approval, phase III confirmatory trials may be needed. The phase III AURA3 trial is underway examining the efficacy and safety of osimertinib vs. platinum-based doublet chemotherapy in EGFR T790M–positive locally advanced or metastatic NSCLC failing EGFR TKI therapy.
Osimertinib (Tagrisso) is approved by the Food and Drug Administration for patients with metastatic EGFR T790M mutation–positive non–small cell lung cancer (NSCLC), the agency announced Nov. 13.
The approval was based on two, single-arm trials, AURA and AURA2, in patients who received osimertinib 80 mg tablets once daily after progressing on systemic therapy, including an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).
First-generation EGFR TKI inhibitors are effective in non–small cell lung cancer (NSCLC), but most tumors develop drug resistance. In nearly two-thirds of cases, the T790 mutation is the culprit.
Osimertinib, a third-generation EGFR TKI, is the first drug to be approved for patients with metastatic EGFR T790M mutation–positive NSCLC. It’s accelerated approval came 3 months ahead of the target approval date of Feb. 6, 2016.
Osimertinib’s approval represents a “milestone for lung cancer patients who urgently needed new treatment options,” and follows one of the fastest development programs, taking a little more than 2.5 years from the first in human clinical trials to approval, according to drug maker AstraZeneca Pharmaceuticals.
Rociletinib, another oral third-generation TKI, is under FDA review for the treatment of previously treated EGFR T790 mutation–positive NSCLC.
The approval of osimertinib was based on tumor response rate and duration of response among 411 patients in the two trials. The objective response rate according to blinded independent review was 57% in AURA and 61% in AURA2 (N Engl J Med. 2015 Apr 30;372[18]:1689-99). Responses were ongoing in most patients in both trials and median duration had not been reached. Ongoing responses ranged from 1.1 months to 5.6 months.
The most common adverse events with osimertinib in the 411 patients were diarrhea (42%), rash (41%), dry skin (31%), nail toxicity (25%), eye disorders (18%), nausea (17%), decreased appetite (16%), and constipation (15%).
The most common grade 3-4 adverse events were pneumonia and pulmonary embolism (2% each).
The full prescribing information for osimertinib is available here.
Under the accelerated approval, phase III confirmatory trials may be needed. The phase III AURA3 trial is underway examining the efficacy and safety of osimertinib vs. platinum-based doublet chemotherapy in EGFR T790M–positive locally advanced or metastatic NSCLC failing EGFR TKI therapy.
Osimertinib (Tagrisso) is approved by the Food and Drug Administration for patients with metastatic EGFR T790M mutation–positive non–small cell lung cancer (NSCLC), the agency announced Nov. 13.
The approval was based on two, single-arm trials, AURA and AURA2, in patients who received osimertinib 80 mg tablets once daily after progressing on systemic therapy, including an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).
First-generation EGFR TKI inhibitors are effective in non–small cell lung cancer (NSCLC), but most tumors develop drug resistance. In nearly two-thirds of cases, the T790 mutation is the culprit.
Osimertinib, a third-generation EGFR TKI, is the first drug to be approved for patients with metastatic EGFR T790M mutation–positive NSCLC. It’s accelerated approval came 3 months ahead of the target approval date of Feb. 6, 2016.
Osimertinib’s approval represents a “milestone for lung cancer patients who urgently needed new treatment options,” and follows one of the fastest development programs, taking a little more than 2.5 years from the first in human clinical trials to approval, according to drug maker AstraZeneca Pharmaceuticals.
Rociletinib, another oral third-generation TKI, is under FDA review for the treatment of previously treated EGFR T790 mutation–positive NSCLC.
The approval of osimertinib was based on tumor response rate and duration of response among 411 patients in the two trials. The objective response rate according to blinded independent review was 57% in AURA and 61% in AURA2 (N Engl J Med. 2015 Apr 30;372[18]:1689-99). Responses were ongoing in most patients in both trials and median duration had not been reached. Ongoing responses ranged from 1.1 months to 5.6 months.
The most common adverse events with osimertinib in the 411 patients were diarrhea (42%), rash (41%), dry skin (31%), nail toxicity (25%), eye disorders (18%), nausea (17%), decreased appetite (16%), and constipation (15%).
The most common grade 3-4 adverse events were pneumonia and pulmonary embolism (2% each).
The full prescribing information for osimertinib is available here.
Under the accelerated approval, phase III confirmatory trials may be needed. The phase III AURA3 trial is underway examining the efficacy and safety of osimertinib vs. platinum-based doublet chemotherapy in EGFR T790M–positive locally advanced or metastatic NSCLC failing EGFR TKI therapy.
