Dr. Munver on the Approval of Mitomycin Gel in Urothelial Cancer

Ravi Munver, MD, vice chairman, chief, Minimally Invasive and Robotic Urologic Surgery, Department of Urology, Hackensack University Medical Center, discusses the approval of mitomycin gel (UGN-101; Jelmyto) in urothelial cancer.

n April 2020, the FDA approved mitomycin gel as the first therapy to treat low-grade upper tract urothelial cancer.

Approval stemmed from results of the phase 3 OLYMPUS trial (NCT02793128), which evaluated the efficacy of the mitomycin gel in urothelial carcinoma tumors of the upper urinary tract, Munver says. Patients received a gel formulation that was placed on the inside of the kidney, and mitomycin gel stayed on the kidney for 4-6 hours before liquefying to pass down the ureter into the bladder, Munver explains. Results showed that 58% of patients achieved a complete response without recurrences of the tumor, Munver adds.

A prediction analysis inferred that approximately 84% of patients would not have a recurrence, Munver continues, noting that not all patients on the trial were followed after 12 months. However, these data compelled the FDA to approve mitomycin gel for this patient population, Munver concludes.