BMS Withdraws Application for Nivolumab/Ipilimumab in TMB-High NSCLC

January 24, 2019 – Bristol-Myers Squibb (BMS) has withdrawn its supplemental biologics license application (sBLA) for the combination of nivolumab and ipilimumab for the frontline treatment of patients with advanced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), following recent discussions with the FDA. The FDA initially accepted the application in June 2018 based on data from the phase III … (leggi tutto)