
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.
Upcoming Events
-
08Sep
-
15Sep
-
20Sep
-
21Sep
-
22Sep
-
11Oct