Home » FDA Approves UroGen Pharma’s Jelmyto for Urothelial Cancer
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.
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