On September 9, 2025, the U.S. Food and Drug Administration approved INLEXZO™ (gemcitabine intravesical system), developed by Janssen Biotech. It is the first device that continuously releases chemotherapy inside the bladder for cancer treatment. Instead of placing liquid chemotherapy in the bladder for one to two hours per visit, this small flexible tube stays in place and slowly releases gemcitabine for three weeks.
The treatment is for adults with BCG-unresponsive, non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors—patients who often previously needed bladder removal surgery. It is given once every three weeks for six months, followed by maintenance every 12 weeks for up to 18 months. The procedure is done in an outpatient setting without general anesthesia.
Approval was based on the Phase 2b SunRISe-1 trial, which showed high complete response rates. The device should not be used in patients with a perforated bladder or gemcitabine allergy, and it may interfere with MRI scans because it contains a small metal wire.