FDA Accepts sBLA for First-Line Nivolumab Plus Low-Dose Ipilimumab in NSCLC With Tumor Mutational Burden ≥ 10 mut/mb

July 2, 2018 – The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for nivolumab plus low-dose ipilimumab for the first-line treatment of advanced non–small cell lung cancer (NSCLC) in patients with a tumor mutational burden ≥ 10 mutations per megabase (mut/mb). The target FDA action date is February 20, 2019. The application was based on results from part 1 of CheckMate-227, the first and only global phase … (leggi tutto)