Primary-source record
MaterialEMA opinion
Merck: Positive EU CHMP Opinion for KEYTRUDA + Padcev in MIBC
CHMP issued a positive opinion recommending approval of KEYTRUDA plus Padcev as perioperative treatment for cisplatin-ineligible resectable MIBC. The opinion is based on statistically significant improvements in EFS, OS, and pCR from the Phase 3 KEYNOTE-905 trial. The European Commission decision is expected in Q3 2026.
Key facts
- Filed
- May 22, 2026, 11:55 AM
- Event
- EMA opinion
- Direction
- Positive
- Company
MRKMerck- Asset
- pembrolizumab
- Source
- Company press release
- Confidence
- Sourced
- OS HR
- 0.50
- EFS HR
- 0.40
- pcr rate
- 57.1% vs 8.6%
- OS median
- NR vs 41.7 months
- EFS median
- NR vs 15.7 months
Source excerpt
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Cisplatin-Ineligible Resectable Muscle-Invasive Bladder Cancer Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Cisplatin-Ineligible Resectable Muscle-Invasive Bladder Cancer Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Cisplatin-Ineligible Resectable Muscle-Invasive Bladder Cancer Opinion granted based on positive event-free survival, overall survival and pathologic complete response rate results from the Phase 3 KEYNOTE-905 trial If approved, this combination would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen for this patient population in the European Union Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev ® (enfortumab vedotin-ejfv), an antibody-drug conjugate (ADC), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC)