WILMINGTON, Del. — AstraZeneca 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 patients with muscle-invasive bladder cancer who are ineligible for or have declined cisplatin-based chemotherapy.
The FDA action date under the Prescription Drug User Fee Act is expected in the fourth quarter of 2026.
Muscle-invasive bladder cancer occurs when a tumor invades the muscle wall of the bladder without distant metastases. AstraZeneca said as many as half of patients may be ineligible for cisplatin-based chemotherapy because of impaired kidney function or other medical conditions.
The supplemental application is based on results from the Phase 3 VOLGA trial. In a planned interim analysis, perioperative treatment with 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 company said the safety and tolerability of the combination were consistent with the known profiles of the individual medicines, with no new safety signals identified.
“This Priority Review reinforces the potential of IMFINZI to become the immunotherapy backbone treatment for muscle-invasive bladder cancer, where patients face high rates of recurrence despite bladder removal surgery. If approved, this would be the first perioperative regimen with enfortumab vedotin given only before surgery; a potentially new standard of care offering practice-changing efficacy and tolerability in this curative-intent setting,” said Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca.
Regulatory applications based on the VOLGA trial are also under review in the European Union, Japan and several other countries.
IMFINZI is already approved in more than 50 countries for patients with cisplatin-eligible muscle-invasive bladder cancer based on the Phase 3 NIAGARA trial.
The drug, in combination with Bacillus Calmette-Guérin induction and maintenance therapy, is also approved in the United States, Japan and other countries for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer based on the Phase 3 POTOMAC trial.
In July 2026, AstraZeneca also reported positive high-level results from the Phase 3 NILE trial, in which IMFINZI plus chemotherapy improved overall survival compared with chemotherapy alone as a first-line treatment for patients with PD-L1-high unresectable, locally advanced or metastatic urothelial cancer.
