What does the FDA's 2026 Keytruda and Padcev approval mean for MIBC patients?

In July 2026, the FDA expanded approval of Keytruda or Keytruda Qlex plus Padcev to all muscle invasive bladder cancer patients eligible for cystectomy, not just those ineligible for cisplatin. The combination improved event‑free and overall survival in the KEYNOTE‑B15/EV‑304 trial, redefining perioperative therapy and signaling major clinical and market shifts for Merck and Astellas.