FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

FDA

9 September 2025 - Today, the FDA approved gemcitabine intravesical system (Inlexzo, Janssen) for adults with Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumours. 

Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.

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Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US , Dossier , Registration