TAR-200 Offers New Hope for BCG-Unresponsive Bladder Cancer

Commentary
Video

Joseph Jacob, MD, discusses the promising impact of TAR-200.

Joseph Jacob, MD, associate professor of urology at Upstate Medical University, highlights the promising impact of TAR-200, a novel intravesical drug delivery system, in the treatment of Bacillus Calmette Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, who are ineligible for or refuse radical cystectomy. Jacob discusses findings from cohort 2 of the phase 2b SunRISe-1 trial (NCT04640623) and emphasizes that TAR-200 may significantly alter the current standard of care.

“I think this is a paradigm shift. I think this is hopefully going to be a drug that gets approved. The new drug application was just submitted, and…[we] now have the opportunity of probably saving at least half of patients from undergoing cystectomy, so that is a huge accomplishment,” he says in an interview with Targeted OncologyTM.

According to Jacob, TAR-200 represents a potential paradigm shift in managing a difficult patient population of those who are ineligible for or refuse radical cystectomy, which is currently the standard treatment in BCG-unresponsive HR-NMIBC. With a new drug application recently submitted, TAR-200 offers hope of avoiding radical bladder removal in at least half of these patients.

TAR-200 is designed as a sustained-release intravesical device that delivers gemcitabine directly into the bladder. It is inserted via a standard hollow catheter, and in clinical use, urologists demonstrated a 99% success rate in device placement, highlighting its ease of use.

Beyond its clinical efficacy, Jacob notes the practical advantages of TAR-200. The device is shelf-stable, easy to store, and requires no special preparation or pharmacy involvement. It comes in simple paper packaging and can be readily deployed or stored as needed, making it extremely logistics-friendly for both providers and patients.

Overall, TAR-200's combination of clinical benefit, ease of administration, and convenience positions it as a potentially transformative option for bladder cancer patients who previously had limited choices. Jacob concludes by emphasizing, “It’s an exciting time [in urology]”, and TAR-200 could significantly expand the therapeutic arsenal for HR-NMIBC.

REFERENCE:
Necchi A, Daneshmand S, Simone G, et al. Practice-changing, Paradigm-shifting Clinical Trials in Urology: TAR-200 monotherapy in patients with bacillus Calmette-Guerin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcome. Presented at: 2025 American Urological Association Annual Meeting. April 26-29, 2025. Las Vegas, NV.

Newsletter

Stay up to date on practice-changing data in community practice.

Recent Videos