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

“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.