The Food and Drug Administration approved Jelmyto to treat patients with low-grade upper tract urothelial cancer.
The Food and Drug Administration (FDA) approved the first drug, Jelmyto (mitomycin gel), to treat patients with low-grade upper tract urothelial cancer, a cancer of the lining of the urinary system.
Upper tract urothelial cancer (UTUC) may block a patient’s ureter or kidney which can cause swelling, infections and impairment of kidney function. Low-grade UTUC is a rare cancer and affects approximately 6,000 to 8,000 patients in the United States every year.
“This is the first approval specifically for patients with low-grade UTUC and provides an option for some patients who may otherwise require a nephroureterectomy,” Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press release.
The approval was based off a study involving 71 patients, of which 58% achieved a complete response following six treatments of Jelmyto that were administered weekly. 19 patients who originally achieved a complete response maintained the response after 12 months of follow-up.
Common side effects of Jelmyto include urinary tract infection, blood in the urine, kidney dysfunction, fatigue, nausea, abdominal pain, painful or difficult urination and vomiting.
“Due to substantial treatment challenges associated with the complex anatomy of the upper urinary tract, many patients need to be treated with radical surgery — usually complete removal of the affected kidney, ureter and bladder cuff. Jelmyto gives patients, for the first time, an alternative treatment option for low-grade UTUC,” Pazdur said in the release.
Check back later for what you need to know about this approval.