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Unituxin Approved for Neuroblastoma

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The United States Food and Drug Administration (FDA) has approved Unituxin (dinutuximab) for treatment of high-risk neuroblastoma among pediatric patients.

The indication for unituxin includes its use in combination with surgery, chemotherapy and radiation therapy among patients who achieved at least a partial regression of their cancer to prior first-line therapy.

Unituxin is an agent that binds to the surface of neuroblastoma cells, signaling the immune system to attack the cancer cells.

The trial that prompted the approval of unituxin included 226 pediatric patients with high-risk neuroblastoma. Following initial therapy, patients were divided into two groups: one group was treated with chemotherapy alone and one group was treated with unituxin in combination with immune-stimulating drugs.

Three years after treatment, 63% of patients treated with unituxin were alive and free of cancer growth, compared with only 40% of patients treated with chemotherapy only.
According to the latest updated survival analysis, 73% of patients treated with unituxin were alive, compared with only 58% treated with chemotherapy only.
Reference: United States Food and Drug Administration (FDA). FDA approves first therapy for high-risk neuroblastoma. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437460.htm.