U.S. Food and Drug Administration (FDA) has granted regular approval to AstraZeneca’s osimertinib (Tagrisso), for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
In November 2015, osimertinib received accelerated approval for this indication based on an overall response rate (ORR) of 59% among 411 patients in two single-arm clinical trials, said FDA and also stated that the current approval is based on AURA3, a randomized, multicenter open-label, active-controlled trial conducted in patients with metastatic EGFR T790M mutation-positive NSCLC who had progressive disease following first-line EGFR TKI therapy.
The presence of an EGFR T790M mutation in a tumor specimen, or plasma specimen (if tumor tissue is unavailable) should be confirmed by an FDA-approved test prior to initiation of treatment.
Tagrisso is the first and only approved medicine in the US indicated for NSCLC patients who have tested positive for the EGFR T790M mutation, noted AstraZeneca in its press release on Monday.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “By following the science, we aim to turn lung cancer into a chronic, manageable disease for patients and this milestone brings us one step closer to that ambition.”
Bohen also said that the FDA’s full approval reinforces the potential of Tagrisso to become the standard of care for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer whose disease has progressed on or after first-generation EGFR-TKI therapy.
FDA previously granted osimertinib Fast Track and Breakthrough Therapy Designation for the current indication, as well as Orphan Drug Designation for the treatment of EGFR mutation-positive NSCLC.