FDA approves first-of-its-kind chemo overdose antidote, Vistogard
- The FDA on Friday approved Vistogard (uridine triacetate) as a first-in-class oral therapy for emergency treatment of chemotherapy overdose. Marketed by Wellstat Therapeutics, the medication is approved specifically to counteract an overdose of either fluorouracil or capecitabine.
- Fluorouracil and capecitabine have been used as standard cancer treatments for many years, especially for treatment of breast and gastrointestinal cancers.
- Vistogard blocks cell damage and cell death caused by fluorouracil chemotherapy. The therapy is intended to be taken as soon as possible after evidence of overdose.
Although chemotherapy overdose is relatively rare, some patients can have severe, and sometimes fatal, reactions to chemotherapy.
In two trials, 135 adult and pediatric cancer patients were given Vistogard following an overdose of fluorouracil or capecitabine or had early-onset severe toxicities from fluorouracil. All of the patients either had evidence of absolute overdose or a severe reaction to treatment within 96 hours of starting treatment. The primary endpoint was survival at 30 days. Overall, 97% of Vistogard-treated patients who had been overdosed were still alive at 30 days. Among patients with a severe toxicity reaction, the survival rate was 89 percent.
Notably, Vistogard is not recommended for non-emergency adverse events, as the medication may lower the overall efficacy of the initial chemotherapy.