AstraZeneca said the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to its supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) in combination with enfortumab vedotin. The proposed treatment is for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy.
The designation is based on results from the Phase III VOLGA trial, which showed statistically significant and clinically meaningful improvements in event-free survival and overall survival.
The FDA’s target action date is anticipated in the fourth quarter of 2026. Priority Review is reserved for applications for medicines that may offer significant improvements in treating serious conditions.