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FDA Grants Priority Review to UGN-101 for Urothelial Cancer

Gina Columbus @ginacolumbusonc
Published: Thursday, Dec 19, 2019

Liz Barrett, president and chief executive officer of UroGen Pharma

Liz Barrett

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.

References

  1. 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.
  2. 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.
  3. 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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