FDA Grants Full Approval to Osimertinib for T790M+ NSCLC

March 30, 2017 – The FDA has granted a regular approval to osimertinib 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 … (leggi tutto)