FDA Accepts Application for Frontline Nivolumab/Ipilimumab in TMB-High NSCLC

June 21, 2018 – The FDA has accepted a supplemental biologics license application (sBLA) for the combination of nivolumab plus ipilimumab for the frontline treatment of patients with advanced non–small cell lung cancer (NSCLC) with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb), according to Bristol-Myers Squibb (BMS), the manufacturer of both immune checkpoint inhibitors. The sBLA is based on findings from the phase III CheckMate-227 trial … (leggi tutto)