U.S. FDA Approves PADCEV® plus Keytruda® as Neoadjuvant and Adjuvant Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility
The FDA approved PADCEV plus Keytruda as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer regardless of cisplatin eligibility. This approval establishes the first platinum-free regimen for this indication, supported by Phase 3 EV-304 data showing a 47% reduction in the risk of tumor recurrence, progression or death versus standard of care.
Key figures
- Drug Name
- PADCEV (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab)
- Phase Of Trial
- Phase 3
- Hazard ratio death
- 0.65
- P CR rate combination
- 55.8%
- Risk reduction death
- 35%
- P CR rate chemotherapy
- 32.5%
- Hazard ratio recurrence
- 0.53
- Risk reduction recurrence
- 47%
- Event free survival 2yr combination
- 79.4%
- Event free survival 2yr chemotherapy
- 66.2%
AI analysis
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