FDA Grants Priority Review to AstraZeneca’s Durvalumab

The FDA granted priority review to AstraZeneca’s biologics license application for durvalumab for the treatment of bladder cancer. The agency set a PDUFA review date in the second quarter of 2017.

The application, for the treatment of patients with metastatic urothelial carcinoma, is based on the results of a Phase I/II trial. Durvalumab was previously granted a Breakthrough Therapy designation by the FDA.

Durvalumab is being tested as monotherapy and in combination with tremelimumab in a Phase III trial as a first-line metastatic bladder cancer treatment. The combination is also being studied in Phase III trials in non-small cell lung cancer and head and neck squamous cell carcinoma, and in earlier-phase trials in gastric, liver, pancreatic and blood cancers.