Jelmyto Approval History
Reviewed by Judith Stewart BPharm Last updated on Apr 30, 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 History and FDA Approval Process for Jelmyto
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.