“PADCEV™ Plus Keytruda® Significantly Improves Survival for Patients with Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility,” by Astellas Pharma Inc. News release; Dec. 17, 2025.

Following the positive outcome, Pfizer and Astellas will seek approval of Padcev-Keytruda in MIBC regardless of a patient’s cisplatin eligibility.

Padcev is approved for use in combination with the programmed death 1 inhibitor Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph) as neoadjuvant treatment and ...

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 ...

Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 patients each year globally. 1 MIBC represents approximately 30% of all bladder cancer cases. 2 The standard ...

PADCEV plus Keytruda is the first and only regimen without platinum-based chemotherapy to improve event-free and overall survival when used before and after surgery in cisplatin-eligible patients with ...

The combination of Keytruda and Padcev is taking another major step toward securing its position as a leading therapy in the treatment of bladder cancer. The PD-1/antibody-drug conjugate pairing ...

In December 2025, Astellas Pharma and Pfizer reported that their Phase 3 EV-304 trial of PADCEV plus Keytruda in muscle-invasive bladder cancer achieved statistically significant improvements in event ...

TOKYO and NEW YORK, Dec. 17, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced positive topline results ...

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 ...

PADCEV plus Keytruda is the first and only regimen without platinum-based chemotherapy to improve event-free and overall survival when used before and after surgery in cisplatin-eligible patients with ...