AstraZeneca receives priority review for perioperative bladder-cancer regimen

The FDA granted priority review to a regimen combining AstraZeneca ($AZN)’s Imfinzi with enfortumab vedotin around surgery for muscle-invasive bladder cancer in patients ineligible for, or declining, cisplatin chemotherapy. Imfinzi is given before and after surgery, while enfortumab vedotin is part of the preoperative treatment. The company expects a regulatory decision in the fourth quarter of 2026.

The application is supported by the Phase 3 VOLGA trial, which showed statistically significant improvements in event-free and overall survival. Detailed numerical results were not supplied in this announcement. AstraZeneca reported no new safety signals beyond the known profiles of the medicines. Priority review accelerates assessment but is not an approval; related applications are also under review in Europe and Japan.

Sources:

• AstraZeneca — FDA priority review, Business Wire release