Bristol-Myers Squibb (BMY) received the US Food and Drug Administration's full approval for Opdivo plus Yervoy as a first-line treatment for adults with unresectable or metastatic hepatocellular carcinoma, a form of liver cancer.
The approval was supported by results from a phase 3 trial, which demonstrated that the combination therapy significantly improved overall survival to 23.7 months, compared with 20.6 months with lenvatinib or sorafenib, reducing the risk of death by 21%, the company said Friday in a statement.
The trial's safety analysis involved 657 patients with 332 receiving Opdivo plus Yervoy, and 53% of those patients experienced serious adverse reactions, the company said.
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