Bristol-Myers Squibb (BMY) said Friday the European Commission has approved Opdivo plus Yervoy as the first-line treatment for adults with unresectable or advanced hepatocellular carcinoma, the most common type of liver cancer.
The company said the approval applies across all 27 EU member states, along with Iceland, Liechtenstein, and Norway.
Bristol-Myers Squibb said the approval is based on a phase 3 clinical study that showed dual immunotherapy treatment with Opdivo, or nivolumab, and Yervoy, or ipilimumab, resulted in median overall survival of 23.7 months and overall response rate of 36.1%.
In the US, the company said its supplemental Biologics License Application for Opdivo plus Yervoy in unresectable hepatocellular carcinoma has a target action date of April 21.
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