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FDA Grants Full Approval to Osimertinib for T790M+ NSCLC

Silas Inman @silasinman
Published: Thursday, Mar 30, 2017

Vassiliki A. Papadimitrakopoulou, MD

Vassiliki A. Papadimitrakopoulou, MD

The FDA has granted a regular approval to osimertinib (Tagrisso) as a treatment for patients with metastatic EGFR T790M mutation-positive non–small cell lung cancer (NSCLC) following prior treatment with an EGFR TKI, based on progression-free survival (PFS) findings from the phase III AURA3 trial.

Several clinical trials continue to assess osimertinib, both as a single agent and in novel combinations. A phase III study is exploring osimertinib in the frontline setting following tumor resection, with or without adjuvant chemotherapy (NCT02511106).
Mok TS, Wu YL, Ahn MJ, et al. The AURA3 Investigators. Osimertinib or platinum–pemetrexed in EGFR T790M–positive lung cancer. N Engl J Med. 2017; 376:629-640.

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