General Information

Jelmyto (mitomycin) is an alkylating drug. 

Jelmyto is specifically indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).

Jelmyto is supplied as a solution for pyelocalyceal use only.  Prior to every instillation, instruct the patient to take 1.3 g of sodium bicarbonate orally the evening prior to, the morning of, and 30 minutes prior to the instillation procedure (total of 3.9 g). General anesthesia, local anesthesia, sedation, prophylactic antibiotics and/or antihistamines may be used at the discretion of the treating urologist. If the patient is to be anesthetized, advise the patient not to take sodium bicarbonate within 30 minutes prior to the treatment. Consider withholding diuretics one day prior to instillation until 4 hours post-instillation.  When instilling Jelmyto, the entire syringe must be emptied within one minute.

The dose of Jelmyto to be instilled is 4 mg per mL via ureteral catheter or a nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg of mitomycin).   Instill Jelmyto once weekly for six weeks.  For patients with a complete response 3 months after Jelmyto initiation, instillations may be administered once a month for a maximum of 11 additional instillations.

Mechanism of Action

Jelmyto (mitomycin) inhibits the synthesis of deoxyribonucleic acid (DNA).  The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking.  At high concentrations of the drug, cellular RNA and protein synthesis are also suppressed.

Side Effects

Adverse effects associated with the use of Jelmyto may include, but are not limited to, the following:

•  ureteric obstruction
• flank pain
• urinary tract infection
• hematuria
• renal dysfunction
• fatigue
• nausea
• abdominal pain
• dysuria
• vomiting

Clinical Trial Results

The FDA granted accelerated approval to Jelmyto based on results from the Phase 3 study, OLYMPUS (Optimized DeLivery of Mitomycin for Primary UTUC Study). The open-label, single-arm study enrolled 74 patients at clinical sites across the U.S. and Israel . Study patients were treated with six weekly instillations of Jelmyto administered via a standard catheter. Four to six weeks following the last instillation, patients underwent a Primary Disease Evaluation (PDE) to determine complete response (CR), the primary endpoint of the study. Data showed a complete response of 58% in the intent-to-treat population and in the sub-population of patients who were deemed not capable of surgical removal at diagnosis. At the 12-month time point for assessment of durability, 19 patients remained in CR, seven had experienced recurrence of disease and nine patients continued to be followed for the 12-month duration of response. Kaplan-Meier analysis estimated 12-month durability at 84%.