OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, safety, 
dosage and administration, and formulary considerations for dinutuximab.
DATA SOURCES: MEDLINE was searched (1964 to January 2016) using the terms 
ch14.18, dinutuximab, immunotherapy, and neuroblastoma. Other information was 
identified from package insert, Biologics License Application, abstracts, news 
releases, and ClinicalTrials.gov.
STUDY SELECTION AND DATA EXTRACTION: Identified English-language articles were 
reviewed. Selected studies included phase I through III.
DATA SYNTHESIS: High-risk neuroblastoma is primarily a childhood cancer with 
5-year survival rates of 40% to 50%. Treatment for high-risk neuroblastoma 
includes induction chemotherapy, surgery, myeloablative chemotherapy with 
autologous hematopoietic stem cell transplant, and radiation therapy. For 
patients achieving clinical remission, limited treatments exist for preventing 
relapse. Dinutuximab is a chimeric, human-murine, anti-GD2 monoclonal antibody 
approved in combination with granulocyte-macrophage colony-stimulating factor 
(GM-CSF), aldesleukin (interleukin-2 [IL-2]), and isotretinoin (13-cis-retinoic 
acid [RA]) for maintenance treatment of pediatric patients with high-risk 
neuroblastoma who achieve at least a partial response to first-line multiagent, 
multimodality therapy. In phase III trials, dinutuximab increased 2-year 
event-free survival and overall survival when compared to standard treatment. 
Severe adverse effects of dinutuximab include pain, hypersensitivity reactions, 
capillary leak syndrome, and hypotension.
CONCLUSIONS: Dinutuximab is the first anti-GD2 monoclonal antibody approved in 
combination with GM-CSF, IL-2, and RA for maintenance treatment of pediatric 
patients with high-risk neuroblastoma who achieve at least a partial response to 
first-line multiagent, multimodality therapy. Ongoing research will determine if 
dinutuximab could be used earlier in treatment, in nonresponders to initial 
therapies, in combination with chemotherapy, or in other cancers.