Posted by Michael Wonder on 15 Apr 2020
FDA approves first therapy for treatment of low grade upper tract urothelial cancer
15 April 2020 - Today, the U.S. FDA approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer. Urothelial cancer is a cancer of the lining of the urinary system.
The primary endpoint was complete response at three months following initiation of therapy.
The FDA granted this application priority review and breakthrough therapy designation, which expedites the development and review of drugs that are intended to treat a serious condition, when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies.
