AstraZeneca (NYSE: AZN) said 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 target date 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 Imfinzi combined with neoadjuvant enfortumab vedotin showed statistically significant improvements in event-free survival and overall survival compared with radical cystectomy with or without approved adjuvant treatment. Full trial results are set to be presented at a forthcoming medical meeting. The safety profile of the combination was consistent with those of the individual medicines, with no new safety signals identified.

VOLGA enrolled 695 patients across 182 centers in 25 countries. The trial evaluated perioperative Imfinzi with or without Imjudo (tremelimumab-actl) in combination with neoadjuvant enfortumab vedotin for patients with muscle-invasive bladder cancer undergoing radical cystectomy.

According to the press release, approximately one in four bladder cancer patients has muscle-invasive disease, and up to 50% of those patients are ineligible for cisplatin-based chemotherapy. Around 15,000 patients are expected to be treated for muscle-invasive bladder cancer in the United States in 2026.

Regulatory applications for the same combination are currently under review in the European Union, Japan, and several other countries. Imfinzi is already approved in the US for cisplatin-eligible muscle-invasive bladder cancer patients based on the NIAGARA Phase III trial.