FDA Approves First Non-Surgical Treatment for Low-Grade Upper Tract Urothelial Cancer

The U.S. Food and Drug Administration approved Jelmyto™ (mitomycin gel) to treat low-grade upper tract urothelial cancer (UTUC), making it the first non-surgical treatment for this indication.

The decision was based on results of the single-arm, phase III ongoing OLYMPUS trial that included 71 patients with low-grade UTUC who had never undergone treatment or had recurrent low-grade non-invasive UTUC with at least one measurable papillary tumor. Patients received mitomycin gel at the recommended dose of 4 mg/mL weekly for six weeks. If they had a complete response (CR), patients could continue treatment for up to 11 additional months.

Complete response observed in more than half of patients

More than half of patients (n=41; 58%) had a CR (primary endpoint) following six treatments of mitomycin gel. Nineteen of these patients (46%) continued to have a CR at 12 months. Median duration of CR was not reached.

The most common adverse events (AEs) associated with mitomycin gel are ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, fatigue, nausea, abdominal pain, dysuria, and vomiting. AEs resulted in 23% of patients discontinuing treatment and 34% having dose interruptions.

Patients with ureteric obstruction may require transient or long-term stents to relieve this obstruction. The obstruction may be persistent and did not resolve or did not resolve completely in 51% of patients who experienced obstruction due to mitomycin gel. Patients with a glomerular filtration rate of less than 30 mL/min should not receive mitomycin gel.