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.

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Ravi Munver, MD, discusses the approval of mitomycin gel in urothelial cancer.


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 utilization of mitomycin gel (Jelmyto) in genitourinary (GU) cancers.

Mitomycin gel is a chemotherapeutic agent that is used to treat low-grade, upper tract urothelial carcinoma, Munver explains. Mitomycin had been an established chemotherapy agent, and the liquid form has been utilized to treat bladder cancers, Munver says. However, patients with tumors in their ureters or kidneys have not had an effective treatment option outside of surgery, and recurrence of these tumors has been frequent, Munver notes.

Prior agents did not have the ability to remain in the ureter or kidney to properly treat tumors, Munver says. Mitomycin gel is the first agent that provides an effective method to treat low-grade, upper tract cancers of the ureter and the kidney by remaining on the disease site for a longer period, and this treatment option can help reduce recurrence, Munver concludes.

Ravi Munver, MD, discusses the utilization of mitomycin gel in genitourinary cancers.


Ravi Munver, MD

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

Dr. Munver on the Utilization of Mitomycin Gel in GU Cancers