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 powers ahead in 2026 with strong Q1 results as pipeline momentum builds

The pharmaceutical giant reported $14.5 billion in revenue, up 5% year-over-year, and reaffirmed its full-year outlook

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

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

The combination also outperformed chemotherapy on another important secondary endpoint