07:33 AM EDT, 08/21/2024 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said Wednesday that the US Food and Drug Administration has accepted the company's supplemental Biologics License Application for Opdivo plus Yervoy to treat adult patients with unresectable hepatocellular carcinoma.

The FDA's acceptance was based on the company's late-stage trial, which showed a "statistically significant and clinically meaningful improvement" in overall survival with Opdivo plus Yervoy as compared to lenvatinib or sorafenib, Bristol Myers said.

The regulator has set April 21 as the Prescription Drug User Fee Act date, the company said.

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