FDA accepts sBLA for priority review of Opdivo in new indication

The US Food and Drug Administration accepted a supplemental Biologics License Application (sBLA) that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC), or liver cancer, after prior treatment with sorafenib (Bayer’s Nexavar).

The FDA granted the application priority review and previously granted Opdivo orphan-drug designation for the treatment of HCC. The FDA action date is September 24, 2017, said the drug’s maker, US pharma major Bristol-Myers Squibb (NYSE: BMY).

Opdivo reported revenues of $1.13 billion in the first quarter of 2017 versus $704 million in the like 2016 quarter.