FDA Approves Inlexzo for Bladder Cancer

bladder

THURSDAY, Sept. 11, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Inlexzo (gemcitabine intravesical system) for the treatment of patients with certain types of bladder cancer.

Specifically, Inlexzo is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The novel approach is designed for patients seeking bladder preservation and is the first and only intravesical drug-releasing system to provide extended local delivery.

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