Positive CHMP Opinion for Astellas' PADCEV (enfortumab vedotin) in combination with KEYTRUDA® for unresectable or metastatic urothelial cancer
Astellas Pharma Inc. announced that on July 26, 2024 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of PADCEVTM (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.
- If approved, enfortumab vedotin in combination with pembrolizumab will be the first and only treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care for those with unresectable or metastatic urothelial cancer
- Positive opinion is based on Phase 3 EV-302 clinical trial results which showed enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival compared to platinum-containing chemotherapy
The positive CHMP opinion is based on data from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which showed enfortumab vedotin in combination with pembrolizumab significantly extends overall survival (OS) and progression-free survival (PFS) compared to platinum-containing chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).