“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.

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 ...

Merck says Keytruda plus Padcev improved survival and response rates versus chemotherapy in a Phase 3 muscle-invasive bladder ...

Pfizer and Astellas now have two studies supporting the use of Padcev with MSD's Keytruda as a perioperative therapy for muscle-invasive bladder cancer (MIBC), raising the prospect of wider use in ...

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 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 ...

Merck MRK announced that the FDA has approved both the intravenous (“IV”) and the subcutaneous (under the skin or SC) formulation of its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), each in ...

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 ...