Low-grade UTUC is a urothelial malignancy that presents in the lining of the upper urinary tract, in the ureters and renal collecting system of the kidneys. It is a rare but critical cancer that affects approximately 6,000-8,000 new patients in the United States every year.1
The standard of care for patients with high-grade UTUC is radical nephroureterectomy (RNU), which is the complete removal of the affected kidney, ureter, and bladder cuff. 1,2
However, due to significant treatment challenges associated with the complex anatomy of the upper urinary tract, up to 80% of low-grade UTUC is also treated with radical surgery, typically RNU.3
Endoscopic tumor resection, a kidney-sparing surgical procedure, is sometimes performed in patients with low-grade disease. However, this approach is typically limited to those who present with a limited number of smaller tumors that can be easily visualized and removed using standard instrumentation.1,3 The upper urinary tract’s anatomical constraints limit the effectiveness of these procedures, and they are associated with high rates of recurrence.4
There are currently no drugs approved by the US Food & Drug Administration (FDA) for the treatment of low-grade UTUC, representing a significant unmet medical need.
UGN-101 (mitomycin gel) for instillation is an investigational drug formulation that utilizes our innovative technology, RTGel™ reverse-thermal hydrogel, for the treatment of low-grade UTUC.
Administered locally via ureteral catheter, UGN-101 is designed to fill and conform to the anatomy of the renal collecting system and dwell for a period of several hours before being excreted via normal urine flow.5