EU approves pembrolizumab‑enfortumab combo for bladder cancer

The European Union has authorized the combination of pembrolizumab and enfortumab vedotin‑ejfv as peri‑operative therapy for adults with surgically resectable muscle‑invasive bladder cancer who are ineligible for cisplatin‑based chemotherapy. The approval, which also includes a subcutaneous form of pembrolizumab that can be administered in under two minutes, is based on the phase 3 KEYNOTE‑905 trial. That study showed a 60 % reduction in event‑free survival risk, a 50 % reduction in overall mortality, and a complete pathological response rate of 57 % versus 8.6 % with surgery alone, making it the first PD‑1 inhibitor paired with an antibody‑drug conjugate for this indication.

Earlier data presented at the ASCO 2026 meeting from the EV‑303 and EV‑302 trials confirmed the combo’s benefit across both muscle‑invasive and locally advanced/metastatic disease, with durable survival advantages and no clinically relevant quality‑of‑life impact. The U.S. FDA had already granted approval in 2025, and the robust trial outcomes underpinned the EU’s decision to make the regimen widely available in Europe.