FDA Starts Speedy Review of Imfinzi in Bladder Cancer

FDA starts speedy review of Imfinzi in bladder cancer

AstraZeneca is closing on FDA approval of a new bladder cancer indication for Imfinzi that could help to fend off encroachment from MSD's Keytruda.

Durvalumab Plus Enfortumab Vedotin Earns FDA Priority Review in MIBC

The FDA granted priority review to perioperative durvalumab plus enfortumab vedotin for cisplatin-ineligible muscle-invasive disease, based on phase 3 VOLGA data.

AstraZeneca’s Imfinzi Plus Enfortumab Vedotin Granted US Priority Review for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

(IN BRIEF) AstraZeneca’s supplemental Biologics License Application for Imfinzi in combination with enfortumab vedotin has been accepted and granted Priority Review by the US FDA for patients with muscle-invasive bladder cancer who are ineligible for or have declined cisplatin-based chemotherapy. … Read the full press release →