FDA Approval Alert: The Need-to-Know | Gemcitabine Intravesical System in BCG-Unresponsive NMIBC

In September 2025, the FDA approved gemcitabine intravesical system for patients who have Bacillus Calmette-Guérin-unresponsive, non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.

How Will Gemcitabine Intravesical System Impact BCG-Unresponsive NMIBC?
How Will Gemcitabine Intravesical System Impact BCG-Unresponsive NMIBC?
Article
Sep 16, 2025 10:00 PM
Gary Steinberg, MD, highlights the FDA approval of the gemcitabine intravesical system and what this means for patients with BCG-unresponsive NMIBC.
In patients who refuse or are ineligible for radical cystectomy, the gemcitabine intravesical system may be given after unsuccessful BCG treatment.
FDA Approves Gemcitabine Intravesical System in BCG-Unresponsive NMIBC
Article
Sep 9, 2025 8:31 PM
In patients who refuse or are ineligible for radical cystectomy, the gemcitabine intravesical system may be given after unsuccessful BCG treatment.