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
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