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.