Pfizer Canada ULC announced today that Health Canada has, under priority review and Project Orbis initiative, approved PADCEV (enfortumab vedotin for injection), in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. Project Orbis is an initiative of the FDA which provides a framework for coordinating submission and review of oncology products among international health authorities, including Health Canada. This approval is based on data from the EV-303 clinical trial, which evaluated this combination as a treatment option before and after surgery for patients who are ineligible for cisplatin-containing chemotherapy.