FDA Grants Frontline Alectinib Priority Review for ALK-Positive NSCLC

August 3, 2017 – The FDA has granted a priority review to a supplemental new drug application (sNDA) for alectinib for the frontline treatment of patients with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC), according to Genentech (Roche), the manufacturer of the second-generation ALK inhibitor. The agency is scheduled to issue a final ruling by November 30, 2017. Alectinib was previously approved for patients with metastatic … (leggi tutto)