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UroGen Pharma highlights results of first post-commercial use review of JELMYTO
The Fly

UroGen Pharma highlights results of first post-commercial use review of JELMYTO

UroGen Pharma highlights results from the first and largest post-commercial utilization review of JELMYTO for pyelocalyceal solution. This study evaluated 132 patients treated with JELMYTO from 15 high-volume academic and community centers and characterizes the manner in which urologists are now using JELMYTO in their practices. The study titled, "Early Experience with UGN-101 for the Treatment of Upper Tract Urothelial Cancer – A Multi-Center Evaluation of Practice Patterns and Outcomes," is published in Urologic Oncology: Seminars and Original Investigations. The authors describe several trends in JELMYTO use that differ from the pivotal Olympus study that led to drug approval. Doctors are using JELMYTO for the treatment of large tumors, high grade tumors, and ureteral tumors. In addition, the report documents the use of JELMYTO as a valuable multimodal adjunct following complete laser tumor ablation. JELMYTO is indicated for the treatment of adult patients with low-grade upper tract urothelial cancer. Primary chemoablation resulted in a 70% complete response rate for patients with tumors less than 1cm while 69% achieved CR when JELMYTO was combined with laser ablation. CR in the Olympus trial was 59%. Almost half of the patients in the review were treated by antegrade administration of JELMYTO through a nephrostomy tube. The Olympus cohort was treated exclusively by retrograde catheter passed into the upper tract through the bladder. The authors of a recent single-center retrospective review observed that antegrade administration of JELMYTO was associated with a lower rate of ureteric stenosis than the retrograde approach as observed in OLYMPUS, and this larger multi-center review supports that earlier observation. The rate of ureteric stenosis in the Olympus trial was 44%. In this multi-center study it was 23%. The limitations of this study include the retrospective design, lack of a control group, the lack of a centralized pathology review, and standardized clinicopathologic assessment.

Published first on TheFly

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