22 Aug 2024: PADCEV® (enfortumab vedotin) in combination with pembrolizumab approved by Health Canada to treat advanced bladder cancer
Health Canada has approved PADCEV® (enfortumab vedotin) in combination with pembrolizumab for treating adult patients with unresectable locally advanced or metastatic urothelial cancer who have not received prior systemic therapy for mUC
The approval is based on the Phase 3 EV-302 clinical trial (KEYNOTE-A39), which showed substantial clinical effectiveness and an improved benefit/risk profile over existing therapies
Findings from EV-302 were presented at the European Society for Medical Oncology (ESMO) 2023 Congress
The approval was granted under Health Canada’s Priority Review process