Opdivo plus Yervoy accepted for priority review in liver cancer by FDA

The US Food and Drug Administration has accepted its supplemental Biologics License Application (sBLA) and granted Breakthrough Therapy designation for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib.

The FDA granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of March 10, 2020, US pharma major Bristol-Myers Squibb (NYSE: BMY) announced today.

“The FDA’s acceptance of our application for Opdivo plus Yervoy represents important progress for patients with liver cancer in the United States, where hepatocellular carcinoma is the fastest rising cause of cancer-related death,” said Dr Ian Waxman, development lead, gastrointestinal cancers, Bristol-Myers Squibb, adding: “Despite recent advances, hepatocellular carcinoma remains a difficult-to-treat cancer and patients are in need of additional effective treatment options. We look forward to working with the FDA to bring the potential of a dual Immuno-Oncology therapy to these patients for the first time.”