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# Imfinzi sBLA Gets Priority Review for Bladder Cancer
- URL: https://www.fdaweb.com/imfinzi-sbla-gets-priority-review-for-bladder-cancer/
- Published: 2026-09-25T11:30:00.000Z
- Updated: 2026-09-25T20:31:01.000Z
- Author: David McFarland
- Tags: Biologics

FDA has accepted for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) in combination with enfortumab vedotin (EV) for treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy. The agency set a user fee review action target date for upcoming fourth quarter.

The sBLA is based on [results](https://www.astrazeneca.com/media-centre/press-releases/2026/imfinzi-ev-improves-efs-os-in-bladder-cancer.html?ref=fdaweb.com) from the VOLGA Phase 3 trial, according to the company. “In a planned interim analysis, perioperative treatment with Imfinzi in combination with neoadjuvant EV demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) versus radical cystectomy (surgery to remove the bladder) with or without approved adjuvant treatment,” it says.

Durvalumab is a programmed death ligand-1, or PD-L1, blocking antibody already approved for several cancer indications, including lung and liver cancers. The prescribing information for Imfinzi includes warnings about immune-mediated adverse reactions, infusion-related reactions, complications following allogeneic hematopoietic stem cell transplantation and embryo-fetal toxicity.