UroGen Pharma Ltd. highlights the results of a sub-analysis from the first post-commercial utilization review of JELMYTO®? (mitomycin) for pyelocalyceal solution. This is the first study to compare modes of administration for JELMYTO, an approved treatment for low-grade upper tract urothelial cancer (LG-UTUC) in adult patients.

Findings from the study titled, Route of Administration for UGN-101 and Impact on Oncological and Safety Outcomes, are published in the European Urology Focus online. In this sub-analysis, 136 renal units were treated in 132 patients (43% via antegrade and 57% via retrograde) with at least one dose of JELMYTO. Investigators reported that the overall rate of stricture occurrence was lower with the antegrade approach (12%) compared to retrograde group (32%).

Although no significant difference in response was observed, the antegrade group showed a higher complete response (CR) rate of 60% compared to 48% in the retrograde group (p=0.1). Partial response (PR) rates were also favorable, with 60% CR and 32% PR for retrograde administration, and 48% CR and 28% PR for retrograde administration. In this study, survival outcomes are reported per patient and treatment, complications and recurrence outcomes are reported per renal unit.

In the OLYMPUS clinical study, data were generated for the retrograde administration of JELMYTO. In that study population, ureteric obstruction was reported in 58% (n=41) of patients receiving JELMYTO, including 17% (n=12) of patients who experienced Grade 3 obstruction. JELMYTO may cause serious side effects, including: Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction).

If develop swelling and narrowing, and to protect kidney from damage, healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell healthcare provider right away if develop side pain or fever during treatment with JELMYTO. Bone marrow problems. JELMYTO can affect bone marrow and can cause a decrease in white blood cell, red blood cell, and platelet counts.

healthcare provider will do blood tests prior to each treatment to check blood cell counts during treatment with JELMYTO. healthcare provider may need to temporarily or permanently stop JELMYTO if develop bone marrow problems during treatment with JELMYTO. The most common side effects of JELMYTO include: urinary tract infection, blood in urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.