New EC approval for BMS’ Opdivo and Yervoy

7 March 2025

US pharma major Bristol Myers Squibb (NYSE: BMY) has announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC).

The approval - valid in all 27 member states of the European Union (EU) as well as Iceland, Liechtenstein and Norway - is based on results of Phase III CheckMate -9DW clinical trial, which showed a statistically-significant and clinically-meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib.

As well as HCC, Opdivo-based options are also approved for treatment of multiple tumor types in the EU.

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