Merck's KEYTRUDA Plus Padcev Receives Positive EU CHMP Opinion
Merck's cancer treatment KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
The recommendation is based on the Phase 3 KEYNOTE-B15 trial, which demonstrated improvements in event-free survival, overall survival, and pathologic complete response rate.
If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen for patients with resectable muscle-invasive bladder cancer (MIBC) regardless of cisplatin eligibility in the European Union.
According to Dr. Marjorie Green, senior vice president, oncology, global clinical development at Merck Research Laboratories, 'Despite advances in the treatment of muscle-invasive bladder cancer, recurrence remains a significant concern for many patients.'