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FDA Approves Pediatric Cancer Drug

By Drug Discovery Trends Editor | March 11, 2015

Microscopic view of a typical neuroblastoma with rosette formation.  (Dr. Maria Tsokos, National Cancer Institute)The U.S. Food and Drug Administration (FDA) has approved Unituxin (dinutuximab), part of a first-line therapy for high-risk neuroblastoma.

The new treatment is approved for use in combination with surgery, chemotherapy and radiation therapy for patients who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

Unituxin is only the third drug that has received initial FDA approval for a pediatric cancer in more than 20 years.

Neuroblastoma, a rare cancer that forms from immature nerve cells, typically occurs in children younger than five years of age. Patients with high-risk neuroblastoma have a 40 to 50 percent chance of long-term survival despite aggressive therapy.

“Unituxin marks the first approval for a therapy aimed specifically for the treatment of patients with high-risk neuroblastoma,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in the agency’s news release. “[This drug] fulfills a critical need by providing a treatment option that prolongs survival in children with high-risk neuroblastoma.”

The FDA granted Unituxin priority review and orphan product designation. Unituxin’s approval was based on the demonstration of improved event-free survival (EFS) and overall survival (OS) in a multicenter, open-label, randomized trial.

The safety and efficacy of the drug were evaluated in a clinical trial of 226 pediatric patients with high-risk neuroblastoma whose tumors shrunk or disappeared after treatment with multiple-drug chemotherapy and surgery followed by additional intensive chemotherapy and who subsequently received bone marrow transplantation support and radiation therapy.

Read the entire news release here.

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Filed Under: Drug Discovery

 

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