FDA grants priority review to AstraZeneca’s Imfinzi combination for bladder cancer

AstraZeneca (AZN) announced that the U.S. Food and Drug Administration has accepted and granted Priority Review to a supplemental Biologics License Application for Imfinzi (durvalumab) in combination with enfortumab vedotin for the treatment of muscle-invasive bladder cancer in patients who are ineligible for or have declined cisplatin-based chemotherapy.

The FDA’s Prescription Drug User Fee Act date, which marks the target deadline for a regulatory decision, is anticipated in the fourth quarter of 2026.

The application is based on results from the VOLGA Phase III trial, in which perioperative treatment with Imfinzi combined with neoadjuvant enfortumab vedotin showed statistically significant improvements in event-free survival and overall survival compared to radical cystectomy with or without approved adjuvant treatment. The trial enrolled 695 patients across 182 centers in 25 countries. Full results are scheduled to be presented at a forthcoming medical meeting.