Joseph Jacob, MD, MSc, Director of Urologic Oncology,

Upstate Medical University, Syracuse, NY.

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In today’s episode, we had the pleasure of speaking with Joseph Jacob, MD, MCR, about the FDA approval of the gemcitabine intravesical system (formerly TAR-200; Inlexzo)​ for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer. Dr Jacob is 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 in Syracuse.

In our exclusive interview, Dr Jacob discussed the significance of this approval, key efficacy findings from the pivotal phase 2b SunRISe-1 trial (NCT04640623), and the TAR-200 administration procedure, which he describes as straightforward for practitioners and convenient for patients.

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Dr Jacob discusses the significance of the FDA approval of the gemcitabine intravesical system for BCG-unresponsive non–muscle-invasive bladder cancer.

FDA Approval Insights: Gemcitabine Intravesical System for NMIBC: With Joseph Jacob, MD, MCR

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). 

​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.

Videos

Joseph Jacob, MD, MCR, discusses the FDA approval of the gemcitabine intravesical system for patients with BCG-unresponsive NMIBC with carcinoma in situ. 

TAR-200

“I would say [TAR-200 represents a] paradigm shift. This drug that has great efficacy, but it's also a different way of treating bladder cancer.”

Joseph Jacob, MD, MCR, an associate professor of urology in the Department of Urology at SUNY Upstate Medical University, emphasized the potential paradigm shift associated with TAR‑200, an investigational intravesical gemcitabine delivery system, for the treatment of patients with BCG-unresponsive, high‑risk non–muscle‑invasive bladder cancer (NMIBC).

On July 17, 2025, the FDA granted priority review to a new drug application seeking the approval of TAR-200 for the treatment of patients with BCG-unresponsive, high-risk NMIBC with carcinoma in situ (CIS), with or without papillary tumors, based on data from the phase 2b SunRISe‑1 trial (NCT04640623).

Findings from SunRISe‑1, presented during a plenary session at the 2025 American Urological Association Annual Meeting, showed that among evaluable patients, TAR‑200 produced a complete response (CR) rate of 82.4%. Moreover, 52.9% of patients who achieved a CR remained disease‑free for at least 1 year.

Jacob noted that TAR‑200 represents a novel method of drug delivery for bladder cancer, with the device placed intravesically to deliver sustained‑release gemcitabine over at least 7 days, in contrast to traditional intravesical therapies such as BCG or chemotherapy instillations, which typically achieve dwell times of 1 to 2 hours. This extended exposure may enhance local drug penetration and efficacy.

The safety profile of TAR‑200 has been favorable, with most treatment‑emergent adverse effects (AEs) reported as mild or moderate in severity. The most common AEs occurring in at least 10% of patients included pollakiuria, dysuria, urinary tract infection, micturition urgency, hematuria, noninfective cystitis, and urinary tract pain. No unexpected safety signals emerged, and there was no indication of increased systemic toxicity related to the device.

Jacob underscored that the innovation lies not only in the efficacy of TAR‑200 but also in its potential to expand the scope of sustained intravesical delivery. Gemcitabine is a well‑established chemotherapeutic agent in bladder cancer, and this platform could be adapted for other agents, opening new opportunities for treatment in BCG‑unresponsive, high-risk NMIBC and potentially other urothelial malignancies.

If approved, TAR‑200 could provide a bladder‑sparing alternative for patients who would otherwise face radical cystectomy, thereby addressing a significant unmet need in this challenging disease setting, Jacob said.

Joseph Jacob, MD, MCR, discusses the potential role of an intravesical gemcitabine delivery system for BCG-unresponsive non–muscle-invasive bladder cancer.

Dr Jacob on the Potential Role for TAR-200 in BCG-Unresponsive, High Risk NMIBC

Joseph Jacob, MD of SUNY Upstate Medical Center AUA 2025

“[TAR-200] allows us to give steady, good doses in the bladder for a much longer period of time.”

Joseph Jacob, MD, MCR, a medical oncologist specializing in bladder cancer, discussed how the emerging data for TAR-200 could represent a significant shift in the treatment paradigm for patients with high-risk, non–muscle-invasive bladder cancer (NMIBC).

TAR-200, a novel intravesical drug delivery system utilizing gemcitabine, differs from traditional intravesical therapies, which are typically administered via catheter-based instillations held in the bladder for 1 to 2 hours. In contrast, TAR-200 provides sustained local drug release that may enhance therapeutic exposure and reduce the logistical burden on patients, Jacob explained.

Data from the phase 2b SunRISe-1 study (NCT04640623) presented by Jacob during the 

 showed that in cohort 2 (n = 85), patients with BCG-unresponsive, high-risk NMIBC with carcinoma in situ with or without papillary disease treated with TAR-200 experienced a complete response (CR) rate of 82.4% (95% CI, 72.6%-89.8%), and patients achieved a 12-month CR rate of 45.9%. The estimated 12- and 24-month CR rates were 52.4% (95% CI, 40.7%-62.8%) and 44.7% (95% CI, 33.1%-55.7%), respectively.

The broader implications of these findings could include future updates to clinical guidelines, which currently prioritize radical cystectomy following lack of response to BCG; Jacob emphasized that the data for TAR-200 provide a strong argument for offering patients a bladder-sparing alternative, particularly given the durability and tolerability observed.

Furthermore, Jacob highlighted that TAR-200 introduces a new approach to the treatment of bladder cancer through the use of a device-based intravesical platform. This innovation could facilitate the delivery of not only gemcitabine but also other therapeutic agents in future clinical development.

Continued investigation into the long-term outcomes and broader applications of TAR-200 will be important to fully characterize its role in the NMIBC treatment landscape, Jacob concluded.

Joseph Jacob, MD, MCR, discusses how emerging data for TAR-200 could represent a shift in the treatment paradigm for patients with high-risk non–muscle-invasive bladder cancer.

Joseph Jacob, MD, MCR

Articles

FDA Approval Insights: Gemcitabine Intravesical System for NMIBC: With Joseph Jacob, MD, MCR

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

Dr Jacob on the Potential Role for TAR-200 in BCG-Unresponsive, High Risk NMIBC

Dr Jacob on the Potential for TAR-200 to Shift the Treatment Paradigm in NMIBC