European Commission approves Keytruda‑Padcev combo for resectable muscle‑invasive bladder cancer
Merck announced that the European Commission has granted approval for Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin‑ejfv) as peri‑operative therapy for adults with resectable muscle‑invasive bladder cancer (MIBC). The decision is based on the Phase 3 KEYNOTE‑B15 trial, which showed a 47% reduction in event‑free survival risk and a 35% reduction in overall‑death risk versus standard chemotherapy, and a 55.8% pathological complete response rate. The approval covers all 27 EU member states plus Iceland, Liechtenstein and Norway.
Why it matters
The approval expands Keytruda’s indication in Europe, giving Merck a new revenue stream in a large oncology market; analysts note it could boost the drug’s growth trajectory (source 2).
Key facts
- 1The European Commission approved Keytruda plus Padcev for peri‑operative treatment of resectable MIBC on 21 Oct 2026. stocktitan.net
- 2The approval applies to all 27 EU member states and the three EEA countries Iceland, Liechtenstein and Norway. stocktitan.net
- 3In the KEYNOTE‑B15 trial, the combination reduced the risk of event‑free survival events by 47% (hazard ratio 0.53, 95% CI 0.41‑0.70). stocktitan.net
- 4The same trial showed a 35% reduction in overall‑death risk (hazard ratio 0.65, 95% CI 0.48‑0.89). stocktitan.net
- 5Pathologic complete response was 55.8% for the combination versus 32.5% for chemotherapy (p < 0.0001). stocktitan.net
- 6Merck’s stock rose about 3.25% at the close of trading following the announcement. rttnews.com
Summary written by AlphAI AI Desk from 7 of 7 sources. Not investment advice. Figures are as stated by the linked sources.