The Food and Drug Administration said it approved United Therapeutics Corp's drug to treat neuroblastoma, a rare cancer that typically occurs in children below 5 years.
Unituxin is the first drug approved to treat high-risk neuroblastoma patients who have a greater chance of tumors recurring or progressing after chemotherapy.
There are an estimated 650 cases of neuroblastoma diagnosed in the United States each year. The disease, slightly more common in boys, forms from immature nerve cells.
Unituxin, a combination of mouse and human DNA, is an antibody that sticks to the surface of the cancer-affected cells and uses the body's immune system to destroy the cells.
The safety and effectiveness of the drug were tested in a clinical trial comprising 226 patients. After three years of treatment, 63 percent of those receiving the drug were alive and free of tumor growth.
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