Experts react to FDA approval of gemcitabine intravesical system in NMIBC

On September 9, 2025, the FDA approved the gemcitabine intravesical system (Inlexzo; previously TAR-200) for adult patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.1 In the following video, hear from experts as they share their thoughts on the impact of the gemcitabine intravesical system for clinical practice.

Specifically, hear from:

• Joshua J. Meeks, MD, PhD, of Northwestern Medicine in Chicago, Illinois
• Bogdana Schmidt, MD, MPH, of the University of Utah Health in Salt Lake City, Utah
• Andrea B. Apolo, MD, of the National Cancer Institute Center for Cancer Research in Bethesda, Maryland

The gemcitabine intravesical system is the first and only intravesical drug releasing system to provide extended local delivery of a cancer medication into the bladder. The system is designed to remain in the bladder for 3 weeks per treatment cycle for up to 14 cycles.

The approval is supported by data from the SunRISe-1 trial (NCT04640623), which showed a complete response rate of 82%, with 51% of patients remaining in complete response for at least 1 year.

REFERENCE

1. U.S. FDA approval of INLEXZO (gemcitabine intravesical system) set to transform how certain bladder cancers are treated. News release. Johnson & Johnson. September 9, 2025. Accessed September 9, 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated