EMA Validates Opdivo and Yervoy Combo for Advanced Liver Cancer

The European Medicines Agency (EMA) has validated Bristol Myers Squibb's Type II variation application for the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first-line treatment for adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. This validation indicates the application is complete and initiates the EMA's centralised review process. In the European Union, 62,000 cases of liver cancer are diagnosed annually, with HCC being the most prevalent type. Despite recent advances, prognosis for advanced HCC remains poor, highlighting the need for more effective treatments.

Dana Walker, M.D., M.S.C.E., Bristol Myers Squibb's vice president and global programme lead for gastrointestinal and genitourinary cancers, expressed the company's eagerness to work with the EMA to provide a new dual immunotherapy option for these patients. The Phase 3 CheckMate -9DW trial demonstrated that Opdivo plus Yervoy significantly improved overall survival (OS) compared to the investigator's choice of lenvatinib or sorafenib, showing the clinical benefit of this combination in a first-line setting. The safety profile of the Opdivo + Yervoy combination was consistent with previously published data, with no new safety signals detected, and managed using established methods.