Thursday, February 11, 2016

FDA approves Vistogard (uridine triacetate) for emergency treatment of chemotherapy overdose

The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children  who receive an overdose of the cancer treatment fluorouracil or  capecitabine, or who develop certain severe or life-threatening 
toxicities within four days of receiving these cancer treatments.

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 "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, M.D., director of the Office of Hematology and Oncology  Products in the 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."
 Fluorouracil (taken by infusion) and capecitabine (taken orally) are similar types of chemotherapy that have been used for decades to treat several types of cancer, including breast and gastrointestinal cancers. An overdose of fluorouracil or capecitabine is rare, but when it occurs,the effects are serious and can be fatal.
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 health care 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 two 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). The studies' primary measure was survival at 30 days or until chemotherapy  could resume if prior to 30 days. Of those who were treated with  Vistogard for overdose, 97 percent were still alive at 30 days. Of those treated with Vistogard for early-onset severe or life-threatening toxicity, 89 percent were alive at 30 days. In both studies, 33 percent of patients resumed chemotherapy in less than 30 days.

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