n September 9, 2025, the FDA approved INLEXZO™ (gemcitabine intravesical system) by Janssen Biotech. It is the first device that releases chemotherapy directly inside the bladder over time. Unlike traditional treatments where liquid chemo stays in the bladder for 1–2 hours, INLEXZO™ is a small tube that stays in the bladder and delivers the drug continuously for three weeks.
The treatment is for adults with BCG-unresponsive, non–muscle-invasive bladder cancer with carcinoma in situ, with or without tumors. Patients receive it every three weeks for six months, then every 12 weeks for up to 18 months. The procedure is quick, done in an outpatient setting, and does not require general anesthesia.
Clinical trials showed high response rates in this hard-to-treat group. INLEXZO™ should not be used by patients with bladder perforation or gemcitabine allergies. It contains a metal wire that may affect MRI scans, but it provides long-lasting treatment with fewer side effects than traditional chemotherapy.