European Commission Approves KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Resectable Muscle-Invasive Bladder Cancer (MIBC)
The European Commission approved KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) as perioperative treatment for adults with resectable muscle-invasive bladder cancer across all 27 EU member states plus Iceland, Liechtenstein and Norway. It is the first and only PD-1 inhibitor plus ADC regimen approved in the EU for MIBC regardless of cisplatin eligibility, based on the Phase 3 KEYNOTE-B15 trial that showed a 47% reduction in event-free survival events and a 35% reduction in risk of death.
Key figures
- Drug Name
- KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv)
- Phase Of Trial
- Phase 3
- Trial
- KEYNOTE-B15 (EV-304)
- Os hazard ratio
- 0.65
- Efs hazard ratio
- 0.53
- Pcr rate control
- 32.5%
- Countries covered
- 27 EU member states plus Iceland, Liechtenstein and Norway
- Os risk reduction
- 35%
- Patients enrolled
- 808
- Efs risk reduction
- 47%
- Pcr rate treatment
- 55.8%
AI analysis
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