FDA Approves Gemcitabine Intravesical System for Non-Muscle Invasive Bladder Cancer

On September 9, 2025, the US Food and Drug Administration (FDA) approved the use of a gemcitabine intravesical system, TAR-200, for the treatment of patients with Bacillus Calmette-Guérin (BCG)–unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors.

This approval was based on results from Cohort 2 of the single-arm, SunRISe-1 trial which included 83 patients with BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumor following transurethral resection. Patients received TAR-200 monotherapy every 3 weeks for 6 months, followed by once every 12 weeks for 18 months. The major efficacy outcome measure was complete response at any time, as defined by negative results for cystoscopy and urine cytology, and duration of response.

The compete response rate was 82%. Of the patients who achieved a complete response, 51% had a duration of response of at least 12 months.

There are warnings and precautions included for risks of administering the gemcitabine intravesical system for patients with a perforated bladder, risk of metastatic bladder cancer with delayed cystectomy, MRI safety, and embryo-fetal toxicity.

The TAR-200 system delivers 225 mg of gemcitabine into the bladder and has an indwelling period of 3 weeks following each insertion prior to removal. The system is inserted once every 3 weeks for up to 6 months, followed by once every 12 weeks for up to 18 months, or until persistent or recurrent high-grade NMIBC, disease progression, or unacceptable toxicity.

Source:

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer. FDA. Published on September 9, 2025. Accessed on September 10, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer