Perioperative Imfinzi plus Enfortumab vedotin received U.S. FDA Priority Review for MIBC

CAR-T Digest - August 2020

25 September 2026: Perioperative Imfinzi plus Enfortumab vedotin received U.S. FDA Priority Review for MIBC

AstraZeneca announced that the U.S. FDA has accepted supplemental Biologics License Application for Imfinzi in combination with Enfortumab vedotin and granted Priority Review for the treatment of patients with muscle-invasive bladder cancer who are ineligible for or have declined cisplatin-based chemotherapy, with a PDUFA decision anticipated in Q4 2026
The Priority Review is based on the phase 3 VOLGA trial, where perioperative Imfinzi plus neoadjuvant EV demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival versus radical cystectomy with or without approved adjuvant treatment
The application addresses a major unmet need in cisplatin-ineligible MIBC, a population representing up to half of patients, who have historically undergone radical cystectomy alone despite substantial risk of disease recurrence following surgery
The regimen combines Imfinzi, a PD-L1 inhibitor, with Enfortumab vedotin, a Nectin-4-directed ADC carrying the microtubule inhibitor MMAE, integrating immune checkpoint blockade with targeted cytotoxic delivery in the curative-intent setting
Strategically, the Priority Review could expand AstraZeneca’s perioperative Imfinzi strategy beyond cisplatin-eligible MIBC into the cisplatin-ineligible population, while positioning EV plus Imfinzi as a potential bladder-preserving-intent treatment backbone before and after radical cystectomy