FDA Approves Gemcitabine Intravesical System in BCG-Unresponsive NMIBC

A total of 82% of patients given gemcitabine intravesical system experienced a complete response, and 51% of patients maintained a response for at least 1 year.

The FDA has approved gemcitabine intravesical system (Inlexzo) for patients who have Bacillus Calmette-Guérin-unresponsive, non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors, according to a press release from the FDA.

Gemcitabine intravesical system was previously known by the name TAR-200.

Results from the phase 2 SunRISe-1 trial (NCT04640623) led to the approval. A total of 82% of patients given gemcitabine intravesical system experienced a complete response (95% CI, 72%-90%). Additionally, 51% of patients maintained a response for at least 1 year.

The most common adverse effects included laboratory abnormalities, like urinary frequency, urinary tract infection, dysuria, micturition urgency, decreased hemoglobin, increased lipase, urinary tract pain, and decreased lymphocytes.

“I see many patients who ultimately become BCG-unresponsive and often face life-altering bladder removal. These patients now may be ideal candidates for the newly approved [gemcitabine intravesical system],” said Sia Daneshmand, MD, principal investigator of the trial, and professor of Urology, Director of Urologic Oncology at the Norris Comprehensive Cancer Center, Keck School of Medicine of the University of Southern California. “In my experience, [the gemcitabine intravesical system] is well-tolerated and delivers clinically meaningful results. This will change the way we treat appropriate patients who haven't responded to traditional therapy.”

Reference

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://tinyurl.com/4zjz22z7