AstraZeneca hails US priority review for Imfinzi for bladder cancer
(Alliance News) - AstraZeneca PLC on Friday said the US Food & Drug Administration granted priority review for its human monoclonal antibody Imfinzi for a form of bladder cancer.
The Cambridge, England-based pharmaceutical company said the US Food & Drug Administration accepted its supplemental biologics license application for Imfinzi, or durvalumab, in combination with enfortumab vedotin and granted it priority review.
The treatment is intended for patients with muscle-invasive bladder cancer who are ineligible for or have declined cisplatin-based chemotherapy.
AstraZeneca expects a regulatory decision during the fourth quarter of 2026.
Susan Galbraith, executive vice president, Oncology Haematology research & development at AstraZeneca, said: "This priority review reinforces the potential of Imfinzi to become the immunotherapy backbone treatment for muscle-invasive bladder cancer, where patients face high rates of recurrence despite bladder removal surgery. If approved, this would be the first perioperative regimen with enfortumab vedotin given only before surgery; a potentially new standard of care offering practice-changing efficacy and tolerability in this curative-intent setting."
AstraZeneca shares rose 1.4% to 12,568.00 pence each on Friday morning in London.
By Tom Budszus, Alliance News slot editor
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