31 January 2025 - Recommendation based on results of Phase 3 CheckMate-9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
Bristol Myers Squibb today announced that the CHMP of the EMA has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma, based on results from the Phase 3 CheckMate-9DW trial.