Rare Disease Report: FDA Approves Unituxin (dinutuximab) for Neuroblastoma in Children
March 26, 2015
The U.S. Food and Drug Administration (FDA) has approved Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma. Dinutuximab is an antibody that binds to the surface of neuroblastoma cells and is being approved for use as part of a multimodality regimen, including surgery, chemotherapy and radiation therapy for patients who achieved at least a partial response to prior first-line multiagent, multimodality therapy.
Neuroblastoma is a rare cancer that forms from immature nerve cells. It usually begins in the adrenal glands but may also develop in the abdomen, chest or in nerve tissue near the spine.
Neuroblastoma typically occurs in children younger than 5 years of age. There are an estimated 650 new cases of neuroblastoma diagnosed in the United States each year. Patients with high-risk neuroblastoma have a 40-50% chance of long-term survival even with aggressive therapy.
Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said:
“Unituxin marks the first approval for a therapy aimed specifically for the treatment of patients with high-risk neuroblastoma.”
“Unituxin fulfills a critical need by providing a treatment option that prolongs survival in children with high-risk neuroblastoma.”
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