First Therapy Approved for High-Risk Neuroblastoma

The FDA today approved the first available treatment option for patients with high-risk neuroblastoma, which occurs most frequently in young children.

Dinutuximab (Unituxin), which binds to the surface of neuroblastoma cells, was granted approval for use in a multimodality regimen that includes surgery, chemotherapy, and radiation therapy in patients who achieved at least a partial response to previous first-line multi-agent, multimodality therapy.

“Unituxin marks the first approval for a therapy aimed specifically for the treatment of patients with high-risk neuroblastoma,” said Richard Pazdur, MD, director of the FDA Office of Hematology and Oncology Products, in a press release. “Unituxin fulfills a critical need by providing a treatment option that prolongs survival in children with high-risk neuroblastoma.”

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