www.fdanews.com/articles/196701-fda-approves-urogen-pharmas-jelmyto-for-urothelial-cancer
FDA Approves UroGen Pharma’s Jelmyto for Urothelial Cancer
April 17, 2020
The FDA approved UroGen Pharma’s Jelmyto (mitomycin gel) as a first treatment for low-grade upper-tract urothelial cancer (UTUC).
The approval was based on the results of a clinical trial involving 71 patients with low-grade UTUC who received Jelmyto once a week for six weeks. A complete response was observed in 41 of the patients.
Jelmyto received priority review, breakthrough therapy, fast-track and orphan drug designations from the FDA.