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Jelmyto FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 3, 2020.

FDA Approved: Yes (First approved April 15, 2020)
Brand name: Jelmyto
Generic name: mitomycin
Dosage form: for Pyelocalyceal Solution
Company: UroGen Pharma Ltd.
Treatment for: Urothelial Carcinoma

Jelmyto (mitomycin) is a novel formulation of the approved alkylating drug mitomycin for the treatment of patients with low-grade upper tract urothelial cancer (LG-UTUC).

  • Jelmyto utilizes sustained release RTGel™ technology to enable longer exposure of urinary tract tissue to mitomycin, enabling the treatment of tumors by non-surgical means. The current standard of care for LG-UTUC includes multiple surgeries.
  • Jelmyto is administered to patients using standard ureteral catheters once weekly for six weeks. Patients may receive up to an additional 11 monthly doses dependent on response.
  • Patients receiving Jelmyto need to take sodium bicarbonate orally the evening prior to, the morning of, and 30 minutes prior to instillation procedure.
  • Patients should be advised that urine can change to a violet to blue color, and contact with urine needs to be avoided for at least six hours post-instillation.
  • The most common adverse reactions (≥ 20%) are ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, fatigue, nausea, abdominal pain, dysuria, and vomiting.

Development Timeline for Jelmyto

Apr 15, 2020Approval  FDA Approves Jelmyto (mitomycin) for Treatment of Low-Grade Upper Tract Urothelial Cancer
Dec 19, 2019UroGen Pharma Announces FDA Filing Acceptance and Priority Review of U.S. New Drug Application (NDA) for UGN-101
Jan  8, 2019UroGen 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)
Dec 17, 2018UroGen Pharma Initiates Rolling Submission of New Drug Application (NDA) for UGN-101 for the Treatment of Low-Grade Upper Tract Urothelial Cancer

Further information

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