FDA grants Priority Review to AstraZeneca's Imfinzi combination

The US Food and Drug Administration accepted AstraZeneca's supplemental Biologics License Application for Imfinzi (durvalumab) in combination with enfortumab vedotin and granted it Priority Review. The application seeks approval for patients with muscle-invasive bladder cancer who are ineligible for or have declined cisplatin-based chemotherapy. The FDA target action date under the Prescription Drug User Fee Act is set for the fourth quarter of 2026.

Around one in four bladder cancer patients has muscle-invasive disease, and up to 50% cannot receive cisplatin-based chemotherapy because of renal impairment or other conditions. The historical standard care for this group has been radical cystectomy alone, which carries high recurrence rates.

The filing relies on the Phase III VOLGA trial. In a planned interim analysis, perioperative Imfinzi combined with neoadjuvant enfortumab vedotin produced statistically significant and clinically meaningful improvements in event-free survival and overall survival compared with radical cystectomy with or without approved adjuvant treatment. The regimen showed no new safety signals.

Similar regulatory applications are under review in the European Union, Japan, and other countries based on the VOLGA data. Imfinzi is already approved in more than 50 countries for cisplatin-eligible muscle-invasive bladder cancer following the Phase III NIAGARA study.