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# sBLA for Padcev–Keytruda Combo in Bladder Cancer
- URL: https://www.fdaweb.com/sbla-for-padcev-keytruda-combo-in-bladder-cancer/
- Published: 2025-10-22T12:00:00.000Z
- Updated: 2026-09-14T15:24:49.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160085

FDA has accepted for priority review an Astellas supplemental BLA for Padcev (enfortumab vedotin-ejfv) in combination with Merck’s Keytruda (pembrolizumab) for treating cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC). The submission seeks approval for the regimen as both a neoadjuvant treatment before surgery and an adjuvant therapy afterward, according to the company. The agency set a user fee review action target date of 4/7.

Padcev is described as an antibody-drug conjugate targeting Nectin-4, a protein highly expressed in bladder cancer. It is currently approved — alone and in combination with Keytruda — for locally advanced or metastatic urothelial cancer. The new filing aims to move the regimen into earlier-stage disease, where curative potential remains highest.

The sBLA is based on data from the Phase 3 EV-303 (KEYNOTE-905) trial, which showed that the Padcev–Keytruda combo cut the risk of recurrence, progression, or death by 60% and the risk of death by 50% compared with surgery alone in cisplatin-ineligible MIBC patients, the company says. Safety findings were consistent with prior studies of the regimen, with no new safety signals reported.