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APRIL 2, 2025

FDA Approves Imfinzi for Muscle-Invasive Bladder Cancer


Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

The FDA has approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy, for adults with muscle-invasive bladder cancer.

Efficacy was evaluated in NIAGARA (ClinicalTrials.gov Identifier: NCT03732677), a randomized, open-label, multicenter, phase 3 trial enrolling 1,063