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.

The approval was based on data from the SunRISe-1 single arm, open-label phase 2b clinical study. More than eight in 10 patients with BCG-unresponsive non-muscle-invasive bladder cancer treated with Inlexzo ac

See Full Page