Bristol Myers Squibb Receives FDA Approval for Opdivo Plus Yervoy in Hepatocellular Carcinoma

Bristol Myers Squibb today announced that the FDA has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for adults with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. In the Phase 3 CheckMate-9DW trial, the combination demonstrated a statistically significant improvement in overall survival compared to sorafenib or lenvatinib. The median OS was 23.7 months for Opdivo plus Yervoy versus 20.6 months for investigator's choice. This approval provides a new immunotherapy combination option for patients with previously treated HCC.