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.

Prospective data observed with the gemcitabine intravesical system may be superior to prior reports of other therapies in BCG-unresponsive NMIBC.
Gemcitabine Intravesical System Offers Tremendous Benefits in NMIBC
Podcast
Sep 29, 2025 12:00 PM
Prospective data observed with the gemcitabine intravesical system may be superior to prior reports of other therapies in BCG-unresponsive NMIBC.
Managing AEs with Gemcitabine Intravesical System in NMIBC
Managing AEs with Gemcitabine Intravesical System in NMIBC
Article
Sep 20, 2025 6:00 PM
Gary Steinberg, MD, compared the AE profile of the gemcitabine intravesical system for BCG-unresponsive NMIBC with other intravesical therapies.
Gemcitabine Intravesical System May Transform Bladder Cancer Treatment
Gemcitabine Intravesical System May Transform Bladder Cancer Treatment
Video
Sep 18, 2025 6:00 PM
Gary Steinberg, MD, discusses the clinical significance of the new FDA-approved gemcitabine intravesical system for BCG-unresponsive NMIBC.
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.