AstraZeneca Gets US FDA Priority Review for Investigative Bladder Cancer Therapy

MT newswire2026/09/25 07:48

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03:48 AM EDT, 09/25/2026 (MT Newswires) -- AstraZeneca (AZN) said Friday the US Food and Drug Administration granted priority review to its application for an Imfinzi combination therapy to treat muscle-invasive bladder cancer. The treatment is intended for patients who cannot or choose not to receive cisplatin-based chemotherapy. The submission is based on a phase 3 trial, which showed the perioperative therapy delivered event-free and overall survival improvements compared with bladder removal surgery with or without approved secondary treatments, the company said. AstraZeneca said the FDA is expected to make a regulatory decision in Q4.

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