AstraZeneca's Imfinzi-based Bladder Cancer Combination Therapy Bags Priority Review in US

02:27 AM EDT, 09/25/2026 (MT Newswires) -- AstraZeneca (AZN.L, AZN.ST) said Friday the US Food and Drug Administration granted priority review to its Imfinzi combination therapy for the treatment of muscle-invasive bladder cancer patients. The approval was backed by the results of the Volga phase 3 trial, where Imfinzi in combination with enfortumab vedotin in perioperative treatment showed meaningful improvements in event-free survival and overall survival, compared with radical cystectomy with or without approved adjuvant treatment. The combination therapy's safety and tolerability profile was in line with the known safety profiles of the individual medicines. The drugmaker expects a regulatory decision in the US during the fourth quarter. Regulatory applications are under review in Europe, Japan and other countries.