PADCEV in combination with Keytruda receives positive CHMP opinion for the treatment of patients with resectable MIBC who are ineligible for cisplatin-based chemotherapy

CAR-T Digest - August 2020

Weekly Digest - May 2026

22 May 2026: PADCEV in combination with Keytruda receives positive CHMP opinion for the treatment of patients with resectable MIBC who are ineligible for cisplatin-based chemotherapy

Astellas Pharma announced that the European Medicines Agency’s CHMP has issued a positive opinion for PADCEV in combination with Keytruda for patients with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy
The positive opinion was backed by results from the Phase 3 EV-303/KEYNOTE-905 trial, where the PADCEV-Keytruda regimen reduced the risk of disease recurrence, progression, or death by 60% and lowered the risk of death by 50% versus surgery alone
Safety findings from the study remained consistent with prior experience, with no new safety signals observed, while the most common treatment-related adverse events included pruritus, alopecia, diarrhea, fatigue, and anemia
The recommendation supports the use of the combination both before surgery as neoadjuvant therapy and after surgery as adjuvant treatment, aiming to reduce recurrence risk in a patient population with historically limited treatment options
If approved by the European Commission, the combination could expand from metastatic urothelial cancer into earlier-stage disease, potentially establishing a new perioperative treatment option for cisplatin-ineligible MIBC patients across Europe