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

Gina Columbus @ginacolumbusonc
Published: Thursday, Jan 24, 2019

lung cancer
Bristol-Myers Squibb (BMS) has withdrawn its supplemental biologics license application (sBLA) for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for the frontline treatment of patients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.1
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