Posted by Michael Wonder on 21 Aug 2024
Bristol Myers Squibb receives US Food and Drug Administration sBLA acceptance for first-line treatment of unresectable hepatocellular carcinoma
21 August 2024 - The US FDA assigned a target action date of 21 April 2025.
Bristol Myers Squibb today announced that the US FDA has accepted the supplemental biologics license application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as potential first-line treatment for adult patients with unresectable hepatocellular carcinoma, based on results from the Phase 3 CheckMate-9DW trial.
