Bristol-Myers' BLA for Opdivo Label Expansion Accepted by FDA

Bristol-Myers Squibb Company BMY announced that the FDA accepted its supplemental Biologics License Application (sBLA) for the label expansion of its blockbuster immuno-oncology drug Opdivo for the indication first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). The FDA set an action date of Feb 20, 2019.06/27/2018
Source: Kidney Cancer Association - Category: Urology & Nephrology Source Type: news