Imfinzi (durvalumab) - (VOLGA)

September 25, 2026: AstraZeneca (NYSE: AZN) said the FDA accepted and granted Priority Review to its supplemental BLA for IMFINZI (durvalumab) plus enfortumab vedotin for perioperative treatment of muscle-invasive bladder cancer in patients who are ineligible for or declined cisplatin-based chemotherapy. The PDUFA action date is anticipated in Q4 2026.

The filing is based on the Phase 3 VOLGA trial. In a planned interim analysis, 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. Safety/tolerability was consistent with the known profiles of the individual drugs, with no new safety signals identified.

VOLGA enrolled 695 patients and compares two IMFINZI-based perioperative regimens, with or without IMJUDO, against surgery-based control. The dual primary endpoint is event-free survival; secondary endpoints include overall survival, pathologic complete response, disease-free survival, and pathologic downstaging.

AstraZeneca said VOLGA results will be presented at a forthcoming medical meeting. Regulatory applications are also under review in the EU, Japan, and other countries.