The FDA Accepts And Grants Priority Review to AstraZeneca’s Supplemental Biologics License Application For Imfinzi (Durvalumab) Combined With Enfortumab Vedotin For Muscle-invasive Bladder Cancer Who Are Ineligible For Or Have Declined Cisplatin-based Chemotherapy

The FDA has accepted and granted priority review to AstraZeneca's Supplemental Biologics License Application for Imfinzi (Durvalumab) in combination with Enfortumab Vedotin. This application targets patients with muscle-invasive bladder cancer who are either ineligible for or have declined cisplatin-based chemotherapy. The priority review status may expedite the approval process, potentially impacting AstraZeneca's market position in oncology treatments.