Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) 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.

“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 Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb. “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.”

This application is based on data from the Opdivo plus Yervoy cohort of the Phase 1/2 CheckMate -040 study evaluating the Immuno-Oncology combination in patients with advanced HCC previously treated with sorafenib. Data from this study were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

The FDA’s Breakthrough Therapy Designation is a process intended to enable timely patient access by expediting the development and review of medicines for serious conditions where preliminary clinical evidence indicates a substantial improvement over available therapies on one or more clinically significant endpoints.