First FDA Approval: Combination Therapy for Rare Childhood Cancer, Neuroblastoma

On March 10, 2015, the Food and Drug Administration (FDA) approved Unituxin™ (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a rare cancer that most often occurs in young children. This approval was the result of a collaborative effort between the National Cancer Institute (NCI), the Children’s Oncology Group, and United Therapeutics Corporation (UTC) for the first approved therapy for pediatric high-risk neuroblastoma.

Development of First Immunotherapy to Treat Chordoma

Cancer vaccines harness the immune system to identify and destroy cancer cells, and are a promising new approach to fighting cancer. In contrast to preventative vaccines, cancer vaccines identify antigens from cancer cells and immunize cancer patients against those antigens to stimulate the body’s immune cells to attack and kill the cancer cells. The National Cancer Institute (NCI) has developed investigational cancer vaccines that induce a specific, targeted immune response against cancer cells expressing the brachyury protein.

Discovery to Commercialization: New Immunotherapy for Rare Childhood Cancer, Neuroblastoma

On March 10, 2015, the U.S. Food and Drug Administration (FDA) approved Unituxin™ (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a rare cancer that most often occurs in young children. This approval was the result of a collaborative effort among the National Cancer Institute (NCI), the Children’s Oncology Group, and United Therapeutics Corporation (UTC) for the first approved therapy for pediatric high-risk neuroblastoma.