FDA Approves Gemcitabine Intravesical System for Non-muscle Invasive Bladder Cancer

On September 9, the FDA approved gemcitabine intravesical system for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.

For more information, read the FDA announcement and the Janssen Biotech press release.

Posted on 9/11/2025