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EU Grants Full Approval to Osimertinib for EGFR T790M-Positive NSCLC

Jason Harris
Published: Wednesday, Apr 26, 2017

Sean Bohen, MD, PhD

Sean Bohen, MD, PhD

The European Union (EU) has granted a full approval to osimertinib (Tagrisso) for the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive non–small cell lung cancer (NSCLC), regardless of prior treatment with an EGFR TKI.

Osimertinib patients reported fewer grade ≥3 AEs, 23% vs 47%. The most frequently reported grade ≥3 events in the chemotherapy arm were neutropenia (12%), anemia (12%), and thrombocytopenia (7%). Incidence of each was less than 1% in the osimertinib group.
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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