First FDA approval for low-grade UTUC
medwireNews: The US FDA has permitted the use of mitomycin gel for the treatment of low-grade upper tract urothelial cancer (UTUC).
“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,” said Richard Pazdur, from the FDA’s Center for Drug Evaluation and Research, in a statement to the press.
The approval for the alkylating drug is based on a clinical trial comprising 71 low-grade UTUC patients, more than half (58%) of whom achieved a complete response at the 3-month timepoint after six doses of mitomycin gel administered weekly. Just under half (46%) of the responders had an ongoing response at 12 months.
The FDA cautions that treatment with the agent can lead to serious side effects, such as ureteric obstruction and urosepsis, and it should not be used in people with impaired renal function (estimated glomerular filtration rate <30 mL/min per 1.73 m2) and women who are pregnant.
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