FDA Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer

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

FDA Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer

Today, the U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC). Urothelial cancer is a cancer of the lining of the urinary system.

Common side effects for patients taking Jelmyto were ureteric obstruction (narrowing or blockage of the ureter that may lead to excess fluid in the kidney due to a backup of urine), flank pain (pain occurring on the side of the body), urinary tract infection, hematuria (blood in the urine), renal dysfunction (inability of the kidney to function in its designed capacity), fatigue, nausea, abdominal pain, dysuria (painful or difficult urination) and vomiting.

Jelmyto can cause serious side effects including ureteric obstruction, flank pain and urosepsis (bacteria in the bloodstream from a urinary tract infection). 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 Jelmyto. Jelmyto should be avoided in patients with a glomerular filtration rate (a test used to check how well the kidneys are working) of less than 30mL/min.

Women who are pregnant should not take Jelmyto because it may cause harm to a developing fetus or newborn baby. The FDA advises health care professionals to tell females of reproductive age to use effective contraception during treatment with Jelmyto, and for six months following the last dose. Male patients with female partners of reproductive potential should also use effective contraception during treatment with Jelmyto and for three months following the last dose.