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

AstraZeneca (NASDAQ: 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.

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 due to renal impairment or other comorbidities. 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 indication are currently under review in the European Union, Japan, and several other countries based on the VOLGA trial data.

Imfinzi is currently approved in more than 50 countries for cisplatin-eligible muscle-invasive bladder cancer patients, based on the NIAGARA Phase III trial.

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