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Wellstat Therapeutics Corporation said that its Vistogard, just approved by FDA as the first and only antidote for emergency treatment of adult and pediatric patients following an overdose of the chemotherapy, will be available on the U.S. market soon.
Wellstat Therapeutics Corporation said that its Vistogard (uridine triacetate), just approved by FDA as the first and only antidote for emergency treatment of adult and pediatric patients following an overdose of the chemotherapy, will be available on the US market “as soon as possible”.
The drug is also approved to treat patients who exhibit early-onset, severe or life-threatening toxicity affecting cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions within 96 hours after the end of treatment with 5-FU or capecitabine. Vistogard will be marketed, sold, and distributed in the United States by Wellstat’s commercialization partner BTG plc.
Vistogard is the “only treatment approved by the FDA for early onset severe toxicities or 5-FU overdose and now will be available to the thousands of patients impacted by this condition,” said Samuel J. Wohlstadter, CEO of Wellstat Therapeutics.
“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,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “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.”
The drugs 5-FU and capecitabine are essential components of combination anticancer regimens that include other chemotherapy agents or radiation to treat solid tumors, including those of the colon, stomach, pancreas, breast, head and neck. Each year, 250,000 to 300,000 patients in the United States receive multiple treatments with 5-FU, typically administered at or near what is considered the maximum tolerated dose.
Life-threatening or even lethal 5-FU or capecitabine toxicities can occur when the drug is administered at a dose or rate greater than intended, or when a patient has unusual susceptibilities to the toxic effects of these drugs due to genetic mutations, impaired clearance or other factors, according to Wellstat. It is estimated that 10% to 20% of patients treated with 5-FU or capecitabine develop severe or life threatening toxicity or experience an overdose, and that approximately 0.5% of patients die from such toxicity.
Vistogard, taken orally, blocks cell damage and cell death caused by fluorouracil chemotherapy. Patients should take Vistogard as soon as possible after the overdose (whether or not they have symptoms) or early-onset (within four days) of severe or life-threatening toxicity. The patient’s healthcare provider will determine when he or she should return to the prescribed chemotherapy after treatment with Vistogard.
The efficacy and safety of Vistogard were studied in 135 adult and pediatric cancer patients who were treated in 2 separate trials and had either received an overdose of flourouracil or capecitabine, or had early-onset, unusually severe or life-threatening toxicities within 96 hours after receiving flourouracil (not due to an overdose).
Of those who were treated with Vistogard for overdose, 97% were still alive at 30 days. Of those treated with Vistogard for early-onset severe or life-threatening toxicity, 89% were alive at 30 days. In both studies, 33% of patients resumed chemotherapy in less than 30 days.
The most common side effects of treatment with Vistogard were diarrhea, vomiting and nausea.