FDA Approves Brigatinib for ALK-Positive NSCLC

April 28, 2017 – The FDA has granted brigatinib an accelerated approval as a treatment for patients with metastatic ALK-positive non–small cell lung cancer (NSCLC) who are resistant to prior crizotinib. The approval is based on findings from the phase II ALTA trial, in which the confirmed objective response rate for brigatinib at 180 mg daily was 53% (95% CI, 43-62) and the median progression-free survival (PFS) was 13.8 months. The ALTA trial enrolled 222 patients with … (leggi tutto)