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# Padcev-Keytruda Combo for Broader Bladder Cancer
- URL: https://www.fdaweb.com/padcev-keytruda-combo-for-broader-bladder-cancer/
- Published: 2026-04-20T12:00:00.000Z
- Updated: 2026-09-14T13:37:40.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161008

FDA has accepted for priority review a Pfizer and Astellas Pharma supplemental BLA for Padcev (enfortumab vedotin-ejfv) that seeks to expand use of a combination regimen for patients with muscle-invasive bladder cancer (MIBC).

The application covers Padcev’s perioperative use in combination with Merck’s Keytruda, a PD-1 inhibitor. If approved, the regimen would be available to MIBC patients regardless of their eligibility for cisplatin chemotherapy, significantly broadening its use, according to the companies.

The combination was previously approved in 11/2025 for patients ineligible for cisplatin. The new filing aims to extend that indication to all patients with MIBC, potentially establishing what the companies describe as a new perioperative standard of care.

The submission is based on data from the Phase 3 EV-304 trial, also known as KEYNOTE-B15, which evaluated the combination in patients eligible for cisplatin-based chemotherapy. Recent data presented at the ASCO Genitourinary Cancers Symposium showed the regimen reduced the risk of disease recurrence, progression, or death by 47% compared with standard neoadjuvant chemotherapy with gemcitabine and cisplatin, according to the companies.

The combination also demonstrated a 35% reduction in the risk of death and a higher pathological complete response rate — 55.8% versus 32.5% for chemotherapy — at the time of surgery.

Safety findings were consistent with prior experience for the combination, with no new safety signals identified, they say.