The USFDA has approved the gemcitabine intravesical system for adult patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) presenting with carcinoma in situ (CIS), with or without papillary tumors. This intravesical system, which contains a nucleoside metabolic inhibitor, works by inducing apoptotic cell death. It is the first and only drug-releasing intravesical system designed to provide sustained local delivery of an anticancer agent directly into the bladder. The therapy is specifically developed for patients aiming to preserve their bladder.
Clinical evidence In a clinical study of 83 patients with a median age of 71 years, the gemcitabine intravesical system achieved a complete response rate of 82%. Among responders, 51% maintained their response for more than 12 months. Dosage and administration Available as a single-dose 225 mg intravesical system Administer…
