EUSA Pharma said the European Commission approved the antibody ch14.18/CHO, dinutuximab beta, to treat children at least 1-year-old affected by neuroblastoma, a form of childhood cancer.
Dinutixumab beta become the only approved immunotherapy in Europe for high-risk nneuroblastoma, an EUSA Pharma release said.
Neuroblastoma is the second most common type of tumor in children and mainly affects children that are under the age of 5. There are at least 1,200 children diagnosed with the disease each year in Europe. By affecting the neural crest cells, which are important in fetal development, the disease can spread very quickly, meaning that at least half of those diagnosed are at “high-risk,” the release said
The approval of dinutuximab beta will allow previously diagnosed “high-risk” patients that have received induction chemotherapy a new opportunity for recovery, the release said.
“Today’s announcement is a leap forward for the children and families affected by neuroblastoma, particularly those who have keenly followed the positive clinical trial results for dinutuximab beta and long anticipated its approval in Europe,” Dr. Juliet Gray, associate professor and consultant in pediatric oncology at University of Southampton, UK, said in the release. “As a clinician working in a highly specialized disease area with limited treatment options, I greatly welcome the availability of this targeted immunotherapy treatment that offers improved results for high-risk neuroblastoma patients used alone or in combination with existing therapies.”
The new drug has orphan drug designation in the United States where the company plans to file the product for approval sometime during 2017.
