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UroGen Highlights New Real-World Safety Data Published in The British Journal of Urology International That Showed a Low Rate of Ureteral Stenosis When Antegrade Administration of JELMYTO® was Used in Patients with Upper Tract Urothelial Carcinoma
-- 32-patient, multi-center study showed 9% occurrence of ureteral stenosis and 10% discontinuation rate -- All three stenosis patients were treated without
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\n-- 32-patient, multi-center study showed 9% occurrence of ureteral stenosis and 10% discontinuation rate\n-- All three stenosis patients were treated without later recurrence or chronic stenosis\n\n PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today highlights results from a retrospective multi-center study of 32 patients evaluating the safety of antegrade administration of JELMYTO (mitomycin) for pyelocalyceal solution via percutaneous nephrostomy tube for the treatment of patients with upper tract urothelial carcinoma (UTUC). The study titled, “Antegrade Administration of Mitomycin Gel for UTUC via Percutaneous Nephrostomy Tube: A Multi-Institutional Retrospective Cohort Study,” provides additional real-world evidence of a favorable safety and tolerability profile for JELMYTO when administered via percutaneous nephrostomy tube and is published in The British Journal of Urology International, November Issue.\n\nThis retrospective study assessed the safety and feasibility of antegrade administration of JELMYTO via a percutaneous nephrostomy tube (PCNT) in 32 patients from four institutions. Each patient received at least one dose of JELMYTO via PCNT for UTUC, 29 of whom completed induction (at least 5 of 6 doses) and underwent primary disease evaluation (PDE) at a median 17 weeks after the last dose of therapy. At a median follow-up of 15 months following initiation of induction therapy, ureteral stenosis (defined as a discrete narrowing of the ureter on direct visual ureteroscopy, or a constriction identified on retrograde pyelogram at the time of ureteroscopy that required dilation or stenting to pass a ureteroscope for upstream visualization) occurred in three (9%) of patients. None of these patients had recurrent stenosis at a median 16 months follow- up. Other adverse events included fatigue (27%), flank pain (19%), urinary tract infection (12%), sepsis (8%), and hematuria (8%). No patient had impaired renal function during follow-up and there were no treatment-related deaths. Seventeen patients (59%) had no evidence of disease at PDE and had not recurred at a median follow-up of 13 months post induction.\n\n“We found that antegrade administration of JELMYTO via a nephro...