April 15, 2020
The U.S. FDA has approved Jelmyto™ (mitomycin gel), manufactured by UroGen Pharma, to treat low-grade upper tract urothelial cancer (UTUC). It is the first drug FDA approved for UTUC.
Urothelial carcinoma (UC) is a cancer that begins in the lining of the urinary system. Most types of UC begin in the bladder, but upper tract UC begins in the kidney or the ureter – a long, thin tube connecting the kidney and bladder. Tumor growth can lead to blockages, swelling, and impairment of kidney function. Low-grade UTUC is typically non-invasive and does not spread from the kidney or ureter. Still, these tumors tend to recur in the urinary system and can require careful management to preserve the urinary tract. Approximately 6,000–8,000 new cases are diagnosed in the United States annually.
In a clinical trial, 58% of patients had a complete response, meaning there were no detectable tumors, after six treatments with Jelmyto. Almost half (46%) of the patients who achieved a complete response maintained that response at the 12-month mark.
Recommended dosing is 4mg/mL administered by a healthcare professional using a ureteral catheter or a nephrostomy tube. Total volume administered is based on volumetric measurements using pyelography, a type of X-ray that produces an image of the renal pelvis and urinary tract. No more than 15mL (60mg of mitomycin) of Jelmyto should be administered in a single treatment. Administration frequency is once every week for the first six weeks. If the patient has a complete response after three months of treatment, administration frequency can be reduced to once per month for 11 additional treatments.
The manufacturer has not yet announced launch or pricing plans.