FDA approves gemcitabine intravesical system for certain bladder cancer patients

The FDA approved gemcitabine intravesical system, sold as Inlexzo, on September 9, 2025, for adults with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The system is co-packaged with a urinary catheter and stylet for insertion into the bladder.

Efficacy was evaluated in Cohort 2 of the SunRISe-1 trial, which enrolled 83 patients. Patients received the system every 3 weeks for 6 months, followed by once every 12 weeks for up to 18 months. The FDA reported a complete response rate of 82% (95% CI: 72, 90), and 51% of patients with a complete response had a response lasting ≥ 12 months. The prescribing information warns about risks involving a perforated bladder, delayed cystectomy, MRI safety, and embryo-fetal toxicity.