Chemotherapy Drug Overdose Antidote Approved by FDA

The FDA recently approved the first and only drug available in the United States to reverse the effects of chemotherapy drug overdose.

The FDA recently approved uridine triacetate (Vistogard), the first and only drug available in the United States to reverse the effects of chemotherapy drug overdose.

This potentially lifesaving game changer in the US market is approved for adults and children who receive an overdose of 5-fluorouracil (5FU) or capecitabine, or develop unusually severe or life-threatening toxicities within 4 days of receiving these cancer treatments. The drug is also approved for patients exhibiting early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system.

“Severe 5FU toxicity has historically been difficult to treat and sometimes resulted in death for those affected. It is important to recognize the signs of severe 5FU and capecitabine toxicity early, which often include unexpected side effects on the first cycle — including gastrointestinal toxicities such as mucositis, central nervous system toxicities such as altered mental state, hematologic toxicities, and even cardiotoxicity,” noted Wen Wee Ma, MD, principal investigator of Vistogard’s clinical development program. “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.”

In clinical studies, overall survival of patients with 5FU toxicity receiving Vistogard was 96%, compared with 16% in historical cases that received standard supportive care measures. Vistogard also helped patients resume chemotherapy sooner, with 33% resuming their cancer treatment within 30 days.

“Severe 5-FU toxicity is an ongoing concern for the oncology community, and in some patients, it may go unrecognized,” stated BTG’s CEO Louise Makin. “Vistogard not only saves lives, but also helps some patients get back to fighting their cancer with chemotherapy.”

During the drug’s clinical development, adverse reactions were experienced by about 2% of patients. Such events included vomiting (10%), nausea (5%), and diarrhea (3%).