Bristol Myers announces FDA accepted supplemental BLA for Opdivo plus Yervoy

Bristol Myers Squibb announced that the FDA has accepted the supplemental Biologics License Application, or sBLA, for Opdivo, or nivolumab, plus Yervoy, or ipilimumab, as potential first-line treatment for adult patients with unresectable hepatocellular carcinoma, or HCC, based on results from the Phase 3 CheckMate -9DW trial. The FDA assigned a Prescription Drug User Fee Act, or PDUFA, goal date of April 21, 2025. The filing was based on the results from the Phase 3 CheckMate -9DW study in which the combination demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to investigator’s choice of lenvatinib or sorafenib. The combination of Opdivo plus Yervoy has been an established second-line treatment for patients with advanced HCC, and these results support the combination becoming a potential new treatment option in the first-line setting. The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified. Results were presented at the 2024 American Society of Oncology Annual Meeting.