Unituxin is the first drug approved to treat high-risk neuroblastoma patients who have a greater chance of tumors recurring or progressing after chemotherapy. Patients with high-risk neuroblastoma have only a 40 to 50 percent chance of long-term survival despite aggressive treatment.
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.
The FDA approved the drug Unituxin (dinutuximab) as part of a combined treatment regimen — including surgery, chemotherapy and radiation therapy — for patients who had at least a partial response to a previous combined treatment program.
“Unituxin fulfills a critical need by providing a treatment option that prolongs survival in children with high-risk neuroblastoma,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in an agency news release.
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.
Unituxin can now be used to battle the a rare form of cancer that forms from immature nerve cells. Dr. John Maris, professor of pediatric oncology at the Children’s Hospital of Philadelphia, says until now, doctors battled the cancer with surgery, radiation and chemotherapy and this gives them a major addition to the arsenal:
“Unituxin is a new therapy that tricks the body into recognizing the cancer has foreign and attacks it with the tools of the child’s own immune system, ” said Dr. John Maris, professor of pediatric oncology at the Children’s Hospital of Philadelphia.