FDA grants priority review to AstraZeneca's Imfinzi combo for bladder cancer

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Go back to FDA grants priority review to AstraZeneca's Imfinzi combo for bladder cancer

Perioperative IMFINZI® (durvalumab) plus neoadjuvant enfortumab vedotin granted Priority Review in the US for patients with muscle-invasive bladder cancer

September 25, 2026 7:00 AM EDT

Based on VOLGA Phase III trial results which demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZenecas supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) in combination with enfortumab vedotin (EV) has been accepted and granted Priority Review in the US for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy.

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available... More