FDA Grants Priority Review to AstraZeneca’s Adjunct HCC Drug

The FDA has granted a Priority Review designation to AstraZeneca’s Biologics License Application (BLA) for tremelimumab as adjunct therapy to the company’s blockbuster drug Imfinzi (durvalumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

Tremelimumab is an anti-cytotoxic T-lymphocyte-associated antigen (CTLA4) antibody. Imfinzi is currently FDA-approved for the treatment of stage III nonsmall-cell lung cancer and for extensive-stage small-cell lung cancer. And the company has submitted a supplemental BLA for the HCC.

The FDA granted both tremelimumab and Imfinzi Orphan Drug designations for the treatment of patients with HCC in January 2020.

The agency grants the Priority Review designation to expedite reviews of drugs that are expected to have a significant impact on the treatment of a disease.