FDA Accepts for Priority Review Application for Opdivo

Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC) 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 is September 24, 2017.


“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 HCC, which is often diagnosed in the advanced stage when treatment options are limited,” Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb said. “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.

Hepatocellular carcinoma (HCC) 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.

HCC is often diagnosed in the advanced stage where treatment options are limited and outcomes are poor, with one-year survival rates in the advanced setting of approximately 44%. For patients who are intolerant to or who have progressed during sorafenib therapy, median survival remains less than 11 months with currently available treatment options.

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