FDA Approves Bristol-Myers Drug Combination for Skin Cancer

By Reuters Staff

Drugmaker Bristol-Myers Squibb Co said the US Food and Drug Administration has approved the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

The company said on Thursday that the approval was based on a late-stage study known as CheckMate-069 that showed the two drugs were more effective than Yervoy alone.

The combination delayed the spread of cancer by 8.9 months compared with 4.7 months for Yervoy.

The two drugs had total sales of $783 million in the first half of the year.

This is the FDA's first and only approval for a combination of two immuno-oncology drugs, Bristol-Myers said.

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