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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Urothelial Cancer |
| Drug: | Jelmyto (mitomycin urothelial gel) (DNA synthesis inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
04/15/2020
Excerpt:
The U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC)...The primary endpoint was complete response at three months following initiation of therapy. A complete response was found in 41 of the 71 patients...
Source:
Title:
SUO 2020: Final Results of the OLYMPUS Study - Durability of Response to Chemoablative Treatment of Low-Grade Upper Tract Urothelial Carcinoma with a Mitomycin-Containing Reverse Thermal Hydrogel
Published date:
12/02/2020
Excerpt:
In this single-arm phase III trial, patients with primary low-grade upper tract urothelial carcinoma underwent 6 once-weekly instillations of UGN-101 (JELMYTO)...presented the key secondary endpoint of durability of response. 29/41 complete responders received at least one maintenance dose, with a median of 6 doses among these 29 patients. At 12 months, 23/31 patients (74.2%) had a persistent complete response. (This was 81.8% estimated 1-year persistent CR by Kaplan-Meier analysis, which would imply a ~48% 12 month CR rate overall.)
