The FDA granted priority review to a supplemental BLA from Bristol-Myers Squibb to extend the use of Opdivo to patients with hepatocellular carcinoma after sorafenib therapy.
Opdivo is an immune checkpoint inhibitor that uses the immune system to help restore the body’s anti-tumor response.
The submission was based on data from a Phase I/II clinical study in advanced HCC patients with and without hepatitis B or C infections.
The agency previously granted Opdivo an Orphan Drug designation for the treatment of HCC. The FDA action date is set for Sept. 24.