FDA Approves Mitomycin Gel for Treatment of Low-Grade Upper Tract Urothelial Cancer

The FDA has approved mitomycin gel (Jelmyto, UroGen Pharma Inc) as the first therapy to treat low-grade upper tract urothelial cancer (UTUC), a cancer of the lining of the urinary system.

The mitomycin gel is an alkylating drug, inhibiting the transcription of DNA into RNA and stopping protein synthesis and taking away the cancer cell’s ability to multiply.

The approval is based on the results of a clinical trial involving 71 patients with low-grade UTUC who had never undergone treatment or had recurrent low-grade noninvasive UTUC with at least 1 measurable papillary tumor.

Patients received mitomycin gel once a week for 6 weeks, and monthly if assessed as a complete response for up to 11 additional months. Efficacy of mitomycin gel was evaluated using urine cytology, ureteroscopy, and biopsy 3 months following the initiation of therapy.

A complete response was found in 41 of the 71 patients following 6 treatments of mitomycin gel administered weekly. Durability of the effect of mitomycin gel in patients with a complete response was also evaluated using urine cytology, ureteroscopy, and biopsy every 3 months for a year following the initiation of therapy. Nineteen patients who achieved complete response continued to have a complete response at the 12-month mark.

Common adverse effects reported were ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, fatigue, nausea, abdominal pain, dysuria, and vomiting.

Patients with ureteric obstruction may require transient or long-term stents to relieve this obstruction, as the obstruction may be persistent; this issue was not resolved completely in 51% of patients who experienced obstruction due to mitomycin gel.

Mitomycin gel should be avoided in patients with a glomerular filtration rate of less than 30mL/min.

REFERENCE

FDA approves first therapy for treatment of low-grade upper tract urothelial cancer. FDA. https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-treatment-low-grade-upper-tract-urothelial-cancer?utm_campaign=FDA%20Approves%20First%20Therapy%20for%20Treatment%20of%20Low-Grade%20Upper%20Tract%20Urothelial%20Cancer&utm_medium=email&utm_source=Eloqua. Published April 15, 2020. Accessed April 15, 2020.