U.S. approval of an antidote for chemotherapy overdosing

U.S. approval of an antidote for chemotherapy overdosing

11 Dec 2015

The FDA has approved uridine triacetate (Vistogard) to treat overdoses of the chemotherapy drugs fluorouracil and capecitabine and to treat severe, early-onset toxicities occurring with correct doses of these agents, the agency announced on Friday, 12/11/2015.

The oral drug blocks the cytotoxic effect of these chemotherapies and is the first to be approved as a toxicity reversal agent, the FDA said. It should be administered as soon as possible after overdoses or severe toxicities are detected, but can be given up to 4 days after chemotherapy administration.


Vistogard reduce the drugs’ anti-cancer efficacy

Vistogard's approval was based mainly on two trials involving 135 adults and children that had 30-day survival and resumption of chemotherapy treatment as outcomes. Survival rates were 97% in cases of overdose and 89% in patients with early-onset toxicity. Across both trials, 33% of patients restarted chemotherapy within 30 days, the FDA said.

The agency stressed that Vistogard is not recommended for treating non-emergency adverse effects from the chemotherapies because its mechanism of action serves to reduce their anti-cancer efficacy. Also, the drug's effects beyond 4 days following chemotherapy administration have not been established. Vistogard is sold by Wellstat Therapeutics in Gaithersburg, Md.

Source: MedPage Today

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