The FDA has granted a priority review designation to a new drug application (NDA) for UGN-101 (mitomycin gel) for the treatment of patients with low-grade, upper tract urothelial cancer (UTUC).1
Previously, the FDA granted UGN-101 orphan drug designation, fast track designation, and, in October 2018, a breakthrough therapy designation for UGN-101 in this setting.
- UroGen Pharma Announces FDA Filing Acceptance and Priority Review of U.S. New Drug Application (NDA) for UGN-101 [news release]. UroGen Pharma. Published December 19, 2019. https://bwnews.pr/2Q1cYxx. Accessed December 19, 2019.
- UroGen Pharma Announces Positive Results of UGN-101 from Pivotal Phase 3 OLYMPUS Trial for the Non-Surgical Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC). UroGen Pharma Ltd. Published January 8, 2019. https://bit.ly/2LX0ogq?rel=0". Accessed January 8, 2019.
- Kleinmann N, Pierorazio P, Matin S, et al. Non-surgical management of low grade upper tract urothelial cancer: an interim analysis of the international multicenter OLYMPUS trial (NCT02793128). J Urol. 2018;199(4S):e1166. doi: 10.1016/j.juro.2018.03.097.
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