AstraZeneca Gets US FDA Priority Review for Investigative Bladder Cancer Therapy
MT Newswires Live
Sep 25
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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