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FDA approves Vistogard for overdose of certain types of chemotherapy
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The FDA today approved uridine triacetate for the emergency treatment of adults and children who had an overdose of fluorouracil or capecitabine or had certain severe or life-threatening toxicities within 4 days of taking the cancer treatments.
“Treating cancer requires not only selecting which drug may be most effective and well tolerated, but ensuring the correct dose is given at proper intervals. While rare, unintentional overdose can occur,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Today’s approval is a first-of-its-kind therapy that can potentially save lives following overdose or life-threatening toxicity from these chemotherapy agents.”
Administered orally, uridine triacetate (Vistogard, Wellstat Therapeutics) blocks cell damage and cell death caused by fluorouracil chemotherapy.
The FDA urges doctors to instruct patients to take uridine triacetate as soon as possible after an overdose — even if the patient does not display any symptoms — or early-onset of life-threatening toxicity.
The FDA based its approval in part from results of two separate trials that included 135 adult and pediatric patients with cancer. Patients had either received an overdose of fluorouracil or capecitabine, or had early-onset, unusually severe or life-threatening toxicities within 4 days of fluorouracil.
Ninety-seven percent of patients administered uridine triacetate met the primary endpoint of OS at 30 days. Eighty-nine percent of patients treated for early-onset severe or life-threatening toxicity met the primary endpoint of OS at 30 days.
Patients (33%) in both studies continued chemotherapy in less than 30 days.
The FDA does not recommend uridine triacetate “for non-emergency adverse reactions associated with fluorouracil or capecitabine because uridine triacetate may lessen the efficacy of the chemotherapy drugs,” according to the release.
The most common adverse events in patients taking uridine triacetate were diarrhea, vomiting and nausea.