- Pfizer Canada received Health Canada approval, under Priority Review and the Project Orbis initiative, for Padcev (enfortumab vedotin) plus pembrolizumab in cisplatin-ineligible adults with muscle-invasive bladder cancer (MIBC).
- The combination is approved as neoadjuvant treatment before radical cystectomy, followed by adjuvant therapy after surgery, offering a new option for patients unable to receive cisplatin-based chemotherapy.
- The approval is supported by results from the Phase 3 EV-303 trial, which evaluated the regimen before and after surgery in cisplatin-ineligible MIBC patients.
- Padcev was previously approved in Canada for locally advanced or metastatic urothelial cancer, with this latest authorization expanding its use into earlier-stage bladder cancer.
Takeaways:
This approval expands Padcev from later-line urothelial cancer into earlier-stage muscle-invasive bladder cancer, which should broaden Pfizer’s addressable market in Canada and strengthen its oncology franchise. Because the regimen is specifically for cisplatin-ineligible patients, it fills an important treatment gap and may drive faster uptake in a clinically underserved population, while Priority Review and Project Orbis also signal regulatory confidence that can support physician adoption and future reimbursement discussions.
Source: CA Newswire
