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FDA Approves AstraZeneca’s Imfinzi Regimen for Bladder Cancer

AstraZeneca’s Imfinzi has won U.S. Food and Drug Administration approval in combination with enfortumab vedotin-ejfv for patients with muscle-invasive bladder cancer, followed by Imfinzi alone after surgery to remove the bladder.

By Money Talk·November 14, 2026·2 min read·698 reads

FDA Approves AstraZeneca’s Imfinzi Regimen for Bladder Cancer

The approval covers Imfinzi as neoadjuvant treatment before surgery and as adjuvant monotherapy afterward. It is based on results from the Phase 3 Volga trial.

Patients who received the regimen had a 49% lower risk of disease progression or recurrence, according to the trial results. On the key secondary endpoint of overall survival, the combination reduced the risk of death by 42% compared with the comparison arm.

FDA Approves AstraZeneca’s Imfinzi Regimen for Bladder Cancer

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