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

FDA grants priority review to Merck’s KEYTRUDA and KEYTRUDA QLEX combos with Padcev for muscle-invasive bladder cancer

The submissions are supported by data from the Phase 3 KEYNOTE-905 trial

FDA approves Merck’s Keytruda in combination with Padcev for treatment of metastatic urothelial cancer

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients

Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer

This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting

Seagen, Astellas and Merck announce results of clinical trial investigating PADCEV with Keytruda for urothelial cancer

Results demonstrated a 64.5% confirmed objective response rate in patients treated with investigational combination of enfortumab vedotin and pembrolizumab

Pfizer and Astellas report groundbreaking results in muscle-invasive 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