FDA to consider extending use of Bristol-Myers’ Opdivo

PRINCETON, N.J. — Bristol-Myers Squibb announced Wednesday that the U.S. Food and Drug Administration accepted a supplemental Biologics License Application that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma after prior sorafenib therapy. The FDA granted the application priority review and previously granted Opdivo orphan-drug designation for the treatment of HCC.

The FDA action date on the application Sept. 24.

“We believe the FDA acceptance of our application for Opdivo with priority review status is an important recognition of the significant unmet need for patients with [hepatocellular carcinoma], which is often diagnosed in the advanced stage when treatment options are limited,” said Dr. Ian M. Waxman, development lead, Gastrointestinal Cancers, Bristol-Myers Squibb. “We are committed to exploring new treatment options for these patients and look forward to working with the FDA to potentially extend the use of Opdivo as a treatment option in this setting.”

The submission was based on data from the Phase 1/2 CheckMate -040 study investigating Opdivo in advanced HCC patients with and without hepatitis B virus or hepatitis C virus infections. Data from this study were recently published in The Lancet and will be presented at the American Society of Clinical Oncology Annual Meeting 2017 during a poster discussion session on June 3, 2017 from 4:45–6:00 PM CDT in Hall D2.

Hepatocellular carcinoma is the most common type of liver cancer and the second most frequent cause of cancer death worldwide. More than 700,000 people around the world, including about 40,000 people in the United States, are diagnosed with HCC each year. The majority of these cases are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, making HBV/HCV the most common risk factors for liver cancer.