Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (NYSE:AZN) announced on Friday that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to its supplemental Biologics License Application for IMFINZI (durvalumab) combined with enfortumab vedotin for patients with muscle-invasive bladder cancer who are ineligible for or have declined cisplatin-based chemotherapy.

The application is based on results from the Phase III VOLGA trial, in which perioperative IMFINZI plus neoadjuvant enfortumab vedotin showed statistically significant and clinically meaningful improvements in event-free survival and overall survival versus radical cystectomy, with or without approved adjuvant treatment.

The FDA's regulatory decision is anticipated in the fourth quarter of 2026.

Approximately one in four bladder cancer patients has muscle-invasive disease, while as many as 50% are ineligible for cisplatin-based chemotherapy because of impaired renal function or comorbidities.

AstraZeneca said the combination's safety and tolerability were consistent with the known safety profiles of the individual medicines, with no new safety signals identified.

Regulatory applications based on the VOLGA results are also under review in the European Union, Japan and several other countries.

IMFINZI is approved in more than 50 countries for cisplatin-eligible muscle-invasive bladder cancer based on the Phase III NIAGARA trial, while additional approvals cover certain non-muscle-invasive bladder cancer patients.