FDA nod to groundbreaking bladder cancer combo therapy for surgery patients

Call it a major milestone in bladder cancer therapy that aims to provide a lifeline for patients who previously had limited options

Pfizer and Astellas Pharma have announced that the groundbreaking bladder cancer combo therapy for surgery has received a nod from the US Food and Drug Administration (FDA).

It's actually for PADCEV (enfortumab vedotin-ejfv) in combination with Keytruda (pembrolizumab) as a perioperative treatment for adults with muscle-invasive bladder cancer (MIBC) who cannot receive cisplatin chemotherapy.

This marks the first FDA-approved regimen to show a survival benefit both before and after bladder-removal surgery for this hard-to-treat patient population. The approval is based on results from the Phase 3 EV-303 trial, presented at the ESMO 2025 Presidential Symposium.

“Half of patients with MIBC face recurrence even after cystectomy, and many cannot receive cisplatin. This approval may be a practice-changing advance, offering real hope where none existed for decades,” said Dr Matthew Galsky, lead investigator at Mount Sinai Tisch Cancer Center.

“This approval comes months ahead of schedule and ushers in a new era for patients long underserved by current treatments,” said Jeff Legos, Chief Oncology Officer at Pfizer. “PADCEV plus Keytruda is positioned to reshape the treatment landscape and offer new hope to patients and families.”

Moitreyee Chatterjee-Kishore, Head of Oncology Development at Astellas, added: “PADCEV plus Keytruda now has the potential to redefine care in earlier-stage MIBC. It is the only FDA-approved antibody-drug conjugate and PD-1 inhibitor combination for cisplatin-ineligible patients.”