Dr Jacob on the FDA Approval of the Gemcitabine Intravesical System for NMIBC

“This is a new drug that's available that works well and is going to be [an] effective therapy for patients going forward. This is a drug that's going to save a lot of bladders."

Joseph Jacob, MD, MCR, an associate professor of urology and the director of Urologic Oncology in the Department of Urology at State University of New York Upstate Medical University, discussed the significance of the FDA approval of the gemcitabine intravesical system (formerly TAR-200; Inlexzo)​ for patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC). 

On ​September 9, 2025, the FDA ​​approved the gemcitabine intravesical system for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors. This regulatory decision was backed by findings from cohort 2 of the phase 2b SunRISe-1 trial (NCT04640623). In this trial, patients treated with gemcitabine intravesical system as monotherapy (n = 83) achieved a confirmed complete response rate of 82% (95% CI, 72%-90%).

This approval is highly significant on multiple levels, Jacob began. At the most fundamental level, it addresses an area of substantial unmet need, he stated. Historically, patients in this population have had limited therapeutic options; available agents were often minimally effective, and the primary alternative was radical cystectomy, a major surgical intervention associated with profound quality-of-life implications, he said. Over the past several years, newer systemic agents have emerged, yet the gemcitabine intravesical system represents a novel and highly effective treatment that offers meaningful clinical benefit, he emphasized. Put simply, from a patient-centered perspective, this drug has the potential to preserve bladder function in a large proportion of patients who otherwise might have required surgical removal, he contextualized.

Equally important is the scientific innovation underlying this therapy, according to Jacob. To date, there has been no precedent for managing bladder pathology, whether malignant or nonmalignant, through an intravesical therapy in this manner, he explained. The gemcitabine intravesical system is a therapeutic advance for bladder cancer and represents a broader paradigm shift in the management of bladder-related diseases, he concluded.