Drug to combat kidney failure from chemotherapy gets FDA approval

A drug to combat kidney failure that some cancer patients suffer after receiving high levels of chemotherapy drug methotrexate has been approved by U.S. regulators with an orphan drug designation.

Voraxaze, made by UK-based BTG International, was approved by the U.S. Food and Drug Administration and will be marketed by the company’s U.S. office in West Conshohocken, Pennsylvania near Philadelphia.

Voraxaze is an enzyme that can reduce methotrexate levels by breaking down the chemotherapy drug to a level that can be flushed from the body, according to a statement from the FDA.

“Prolonged exposure to high levels of methotrexate can result in kidney and liver damage, severe mouth sores, damage to the lining of the intestine, skin rashes and death due to low blood counts,” Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, said in a press statement. “Voraxaze is an important new treatment option for cancer patients aimed at preventing these toxicities associated with sustained high levels of methotrexate.”

Voraxaze received an orphan drug designation because fewer than 200,000 people will use the drug. There are no other drugs currently FDA-approved to clear MTX toxicity, an FDA spokeswoman said.

The most common treatment for cancer patients who suffer from kidney failure due to high doses of methotrexate is dialysis, which is associated with higher levels of morbidity, the FDA spokeswoman said.

Although BTG is handling the U.S. market for the drug, it is looking for partners to commercialize the drug in other countries and “who would be able to complete the final development,” according to its website.