Perioperative Imfinzi combined with neoadjuvant enfortumab vedotin secures Priority Review status in the US for muscle-invasive bladder cancer patients

Decision follows Phase III VOLGA trial results, which showed statistically significant and clinically meaningful gains in both event-free survival and overall survival

The U.S. Food and Drug Administration has accepted and granted Priority Review to AstraZeneca’s supplemental Biologics License Application for Imfinzi (durvalumab) combined with enfortumab vedotin, intended for patients with muscle-invasive bladder cancer who cannot receive or have declined cisplatin-based chemotherapy.

Priority Review is a designation the FDA reserves for applications involving medicines that, if approved, would represent a meaningful step forward over existing treatment options, whether through improved safety or effectiveness, prevention of serious conditions, or better patient adherence. The agency’s target action date under the Prescription Drug User Fee Act is expected sometime in the fourth quarter of 2026.

Roughly one in four bladder cancer patients has muscle-invasive disease, meaning the tumor has grown into the bladder’s muscular wall but has not spread to distant sites. Up to half of these patients cannot receive cisplatin-based chemotherapy because of reduced kidney function or other coexisting health conditions. Historically, the standard approach for this group has been surgical removal of the bladder alone, yet even after undergoing this major operation, patients frequently see their cancer return and face a difficult long-term outlook.

Susan Galbraith, executive vice president of oncology haematology research and development at AstraZeneca, said the Priority Review designation strengthens the case for Imfinzi to become the core immunotherapy used in treating muscle-invasive bladder cancer, a setting where patients continue to face high recurrence rates even after having their bladder removed. She said that if approved, this would mark the first perioperative regimen to pair with enfortumab vedotin given exclusively before surgery, potentially establishing a new standard of care with the ability to meaningfully change both outcomes and tolerability in this setting, where the goal of treatment is cure.

The application is supported by findings from the Phase III VOLGA trial, which are set to be presented at an upcoming medical conference. In a planned interim analysis, perioperative treatment combining Imfinzi with neoadjuvant enfortumab vedotin produced statistically significant and clinically meaningful improvements in both event-free survival and overall survival, compared with radical cystectomy, the surgical removal of the bladder, given either alone or alongside approved adjuvant treatment.

The safety and tolerability profile of the Imfinzi and enfortumab vedotin combination matched what is already known about each medicine individually, with no new safety concerns identified.

Regulatory reviews based on the VOLGA trial results are currently underway in the European Union, Japan, and several additional countries.

Imfinzi already holds approval in more than 50 countries for patients with cisplatin-eligible muscle-invasive bladder cancer, based on results from the Phase III NIAGARA trial. The combination of Imfinzi with Bacillus Calmette-Guérin induction and maintenance therapy is approved in the U.S., Japan, and other countries for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer, supported by the Phase III POTOMAC trial. In July 2026, top-line results from the Phase III NILE trial showed that Imfinzi combined with chemotherapy delivered a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy alone, when used as a first-line treatment for patients with PD-L1 high, unresectable, locally advanced, or metastatic urothelial cancer.

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Related Topics and Keywords

Imfinzi, muscle-invasive bladder cancer, neoadjuvant enfortumab vedotin, Perioperative, Perioperative Imfinzi