US regulators have issued a speedy green light for the first and only drug able to treat chemotherapy overdose or severe allergic reactions.

The decision allows doctors to use Wellstat/BTG’s Vistogard (uridine triacetate) to treat patients following an overdose of 5-fluorouracil (5-FU) or capecitabine, or in patients exhibiting early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system. 

In combination with other drugs or radiation, 5-FU is a mainstay of chemotherapy across various solid tumours, and capecitabine is a prodrug of the chemotherapy that is enzymatically activated within the body and transformed into 5-FU.

Potentially life-threatening or lethal toxicity can occur if the chemotherapy has been administered at a dose or rate greater than intended, or when a patient has genetic variations or other factors that increase susceptibility to the toxicities of the drug.

“Severe 5-FU toxicity has, historically, been difficult to treat and sometimes resulted in death for those affected…The approval of Vistogard is important because it represents the first treatment with a demonstrated track record of efficacy and, just as important, it allows some patients to resume chemotherapy sooner following the resolution of the toxicity,” said trial investigator Wen Wee Ma, associate professor of Oncology, GI Cancers & Drug Development Programme, Roswell Park Cancer Institute.

Approval was based on clinical data showing that overall survival of patients with 5-FU toxicity receiving a single course Vistogard (10g given orally every six hours for a total of 20 doses) was 96 percent, compared with 16 percent in historical cases employing standard supportive care measures. The drug also helped patients resume chemotherapy sooner, with 33 percent resuming cancer treatment within 30 days.

On the safety side the Vistogard was also well tolerated, with adverse events occurring in greater than 2 percent of patients vomiting (10%), nausea (5%) and diarrhoea (3%).