NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer

If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy

EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer

Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival

Merck wins FDA priority review for KEYTRUDA bladder cancer combo expansion

If approved, the move would significantly broaden the use of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev

Astellas & Pfizer win FDA priority review for bladder cancer treatment expansion

A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline

Pfizer and Astellas report groundbreaking results in muscle-invasive bladder cancer trial

Merck’s KEYTRUDA–Padcev combo delivers survival gains in Phase 3 bladder cancer trial

Astellas & Pfizer report breakthrough Phase 3 results in muscle-invasive bladder cancer

The combination also outperformed chemotherapy on another important secondary endpoint

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

FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients

The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy

Merck advances cancer innovation by expanding role of Keytruda across new tumor

The company will present new data from across over 20 cancer types and multiple treatment settings at European Society for Medical Oncology Congress 2025