On June 2, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, reported the presentation of the uTRACT Registry study design at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (Press release, UroGen Pharma, JUN 2, 2025, View Source [SID1234653627]). The uTRACT Registry is a single-arm, multicenter, prospective and retrospective study evaluating the real-world use of JELMYTO (mitomycin) for pyelocalyceal solution for the treatment of adult patients with low-grade upper tract urothelial carcinoma (LG-UTUC) across the United States.
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"By capturing these real-world insights, the uTRACT Registry will inform best practices in the management of LG-UTUC," said Mark Schoenberg, Chief Medical Officer, UroGen. "This robust data set aims to support the ongoing clinical utility of JELMYTO in managing LG-UTUC, offering new insights into treatment patterns, long-term outcomes, and patient safety in real-world settings."
As of May 2025, the uTRACT Registry (NCT05874921) has enrolled 274 participants across 22 clinical sites nationwide, with a target enrollment of approximately 400 patients. Of these, about 340 are expected to have LG-UTUC, the population for which JELMYTO is FDA-approved. The study is designed to collect comprehensive data over a three-year period. This includes patient history and baseline disease characteristics prior to initiating treatment with JELMYTO, as well as details on the mode of administration, dosing regimens, surveillance endoscopy findings, and imaging results. Investigators will assess key clinical outcomes such as the presence of no evidence of disease at three months post-treatment, duration of response, recurrence-free survival, time to recurrence or progression, and adverse events.
About JELMYTO
JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel approved for the treatment of adult patients with LG-UTUC. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through a nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.
About Upper Tract Urothelial Cancer
Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as UTUC. In the U.S., there are approximately 6,000 – 7,000 new or recurrent LG-UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often have multiple comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). Treatment with endoscopic surgery can be associated with a high rate of recurrence and relapse.