FDA approves Unituxin for high-risk neuroblastoma

The US Food and Drug Administration today approved US biotech firm United Therapeutics’ (Nasdaq: UTHR) Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.

Neuroblastoma is a rare cancer that forms from immature nerve cells. It usually begins in the adrenal glands but may also develop in the abdomen, chest or in nerve tissue near the spine. Neuroblastoma typically occurs in children younger than five years of age. According to the National Cancer Institute, neuroblastoma occurs in around one out of 100,000 children and is slightly more common in boys. There are an estimated 650 new cases of neuroblastoma diagnosed in the USA each year. Patients with high-risk neuroblastoma have a 40% to 50% chance of long term survival despite aggressive therapy.

First therapy for high-risk neuroblastoma