Logo

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

Share this

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


Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions