AstraZeneca said the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to its supplemental Biologics License Application for Imfinzi in combination with enfortumab vedotin. The treatment is intended for patients with muscle-invasive bladder cancer who are ineligible for or have declined cisplatin-based chemotherapy. [1, 2, 3, 4]
The application is supported by positive results from the Phase III VOLGA trial. [2, 4]
Priority Review accelerates the FDA’s decision timeline. A decision is anticipated in the fourth quarter of 2026. [1, 3]
If approved, the combination could become a new standard of care in a curative-intent setting for this patient group. [3, 4] AstraZeneca shares rose 1.4% in London trading on Friday morning following the announcement. [3]