MAR 13, 2015 2:12 PM PDT

FDA Approves Pediatric Cancer Drug

WRITTEN BY: Ilene Schneider
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.
About the Author
  • Ilene Schneider is the owner of Schneider the Writer, a firm that provides communications for health care, high technology and service enterprises. Her specialties include public relations, media relations, advertising, journalistic writing, editing, grant writing and corporate creativity consulting services. Prior to starting her own business in 1985, Ilene was editor of the Cleveland edition of TV Guide, associate editor of School Product News (Penton Publishing) and senior public relations representative at Beckman Instruments, Inc. She was profiled in a book, How to Open and Operate a Home-Based Writing Business and listed in Who's Who of American Women, Who's Who in Advertising and Who's Who in Media and Communications. She was the recipient of the Women in Communications, Inc. Clarion Award in advertising. A graduate of the University of Pennsylvania, Ilene and her family have lived in Irvine, California, since 1978.
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