AstraZeneca's Muscle-Invasive Bladder Cancer Treatment Gets FDA Approval

Dow Jones

Mar 31, 2025

By Denny Jacob

AstraZeneca's treatment for adults with muscle-invasive bladder cancer was approved in the U.S.

The U.K. drugmaker said Monday that Imfinzi was approved by the Food and Drug Administration after AstraZeneca secured priority review for it, and that the approval was based on a Phase 3 trial. Specifically, approval was granted to it in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as a treatment after radical cystectomy, or surgery to remove the bladder.

Imfinzi is also approved in Brazil. Regulatory applications are currently under review in the European Union, Japan and several other countries.

Write to Denny Jacob at denny.jacob@wsj.com

(END) Dow Jones Newswires

March 31, 2025 07:38 ET (11:38 GMT)

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