First and only combination regimen to improve survival when used before and after surgical cystectomy in cisplatin-ineligible patients with muscle-invasive bladder cancer Unprecedented survival ...

The FDA has prioritized reviewing Padcev and Keytruda for MIBC patients ineligible for cisplatin chemotherapy, with a target action date of April 7, 2026. Phase 3 EV-303 trial results showed a 60% ...

PADCEV plus KEYTRUDA is the first and only regimen to improve survival when used before and after standard of care (surgical cystectomy) in cisplatin-ineligible patients with muscle-invasive bladder ...

First and only systemic therapy to improve survival when used before and after surgery for patients with MIBC who are ineligible for cisplatin-based chemotherapy First ever positive Phase 3 study in ...

The experts agreed that perioperative approaches in muscle-invasive bladder cancer continue to evolve. Ongoing data will ...

The most common adverse events reported in the neoadjuvant and adjuvant pembrolizumab plus enfortumab vedotin arm were pruritus, alopecia, diarrhea, fatigue and anemia. No new safety signals were ...

TOKYO, Oct. 22, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) accepted for ...

First and only systemic regimen to demonstrate durable survival benefit in this patient population KEYNOTE-905 marks the fifth study of a KEYTRUDA-based regimen in an earlier stage of cancer to ...

TOKYO and NEW YORK, Oct. 18, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced positive results from the ...

Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 people each year globally, including an estimated 85,000 people in the U.S. 2,3 MIBC represents approximately ...