FDA Approves UroGen Pharma’s Jelmyto for Urothelial Cancer

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.