FDA News

FDA grants priority review to Opdivo for advanced liver cancer

The FDA granted priority review to nivolumab for the treatment of hepatocellular carcinoma, according to the drug’s manufacturer.

The designation applies to use of nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 immune checkpoint inhibitor, in patients previously treated with sorafenib (Nexavar, Bayer).

The supplemental biologics license application included data from the phase 1/phase 2 CheckMate-040 study, designed to evaluate nivolumab in patients with advanced liver cancer with and without hepatitis B virus or hepatitis C virus infections.

Data from the trial will be presented at the ASCO Annual Meeting, which will be held June 2-6 in Chicago.

The FDA is expected to make a decision on the application by 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,” Ian M. Waxman, MD, development lead for gastrointestinal cancers at Bristol-Myers Squibb, said in a company-issued press release. “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 FDA previously granted orphan drug designation to nivolumab for the treatment of hepatocellular carcinoma.

Nivolumab is approved for several indications, including treatment of certain patients with melanoma, non–small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, and urothelial carcinoma.

The FDA granted priority review to nivolumab for the treatment of hepatocellular carcinoma, according to the drug’s manufacturer.

The designation applies to use of nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 immune checkpoint inhibitor, in patients previously treated with sorafenib (Nexavar, Bayer).

The supplemental biologics license application included data from the phase 1/phase 2 CheckMate-040 study, designed to evaluate nivolumab in patients with advanced liver cancer with and without hepatitis B virus or hepatitis C virus infections.

Data from the trial will be presented at the ASCO Annual Meeting, which will be held June 2-6 in Chicago.

The FDA is expected to make a decision on the application by 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,” Ian M. Waxman, MD, development lead for gastrointestinal cancers at Bristol-Myers Squibb, said in a company-issued press release. “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 FDA previously granted orphan drug designation to nivolumab for the treatment of hepatocellular carcinoma.

Nivolumab is approved for several indications, including treatment of certain patients with melanoma, non–small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, and urothelial carcinoma.