UroGen's Jelmyto Receives the US FDA's Expedited Approval as a Novel Non-Surgical Treatment for Patients with Low-Grade Upper Tract Urothelial Cancer
Shots:
- The approval is based on P-III OLYMPUS trial results assessing Jelmyto in 74 adults with LG UTUC to evaluate its safety- tolerability and tumor ablative effect across the US and Israel
- The study resulted in CR 58%- Kaplan-Meier analysis estimated 12-month durability at 84%- median duration of response has not been reached- no treatment-related deaths occurred
- Jelmyto (mitomycin for pyelocalyceal solution) is a mitomycin- has also received the US FDA’s ODD- Fast Track- and Breakthrough Therapy Designations for the treatment of LG UTU
Click here to read full press release/ article | Ref: UroGen Pharma | Image: Behnace
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