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FDA Grants Full Approval to Osimertinib for T790M+ NSCLC

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.

In the randomized trial, osimertinib demonstrated a median PFS of 10.1 months compared with 4.4 months for standard platinum-based chemotherapy (HR, 0.30; P <.001). Osimertinib was originally granted an accelerated approval in November 2015, based on an overall response rates (ORR) of 59% across 2 single-arm studies. The median PFS for patients with central nervous system (CNS) metastases was 8.5 months with osimertinib versus 4.2 months with chemotherapy (HR, 0.32).

“These results show that osimertinib demonstrated a superior, clinically meaningful efficacy over platinum–pemetrexed, establishing the new standard of care for these patients,” said lead investigator Vassiliki A. Papadimitrakopoulou, MD, form the MD Anderson Cancer Center, when she presented the findings at the IASLC 17th World Conference on Lung Cancer. “Patients receiving osimertinib experienced a 70% reduction in the risk of disease progression without severe toxicity, and similar efficacy was seen in patients with CNS metastases at baseline.” Click here to read the full article at

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