title: Dinutuximab: An Anti-GD2 Monoclonal Antibody for High-Risk Neuroblastoma.
abstract: OBJECTIVE
  To review the pharmacology, pharmacokinetics, efficacy, safety, dosage and administration, and formulary considerations for dinutuximab.
  
  
  METHODS
  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.
  
  
  METHODS
  Identified English-language articles were reviewed. Selected studies included phase I through III.
  
  
  RESULTS
  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.
authors.affiliation: Virginia Commonwealth University Health System/Medical College of Virginia Hospitals, Richmond, VA, USA.
authors.forename: Cady
authors.initials: C
authors.lastname: Ploessl
authors.affiliation: Virginia Commonwealth University Health System/Medical College of Virginia Hospitals, Richmond, VA, USA.
authors.forename: Alice
authors.initials: A
authors.lastname: Pan
authors.affiliation: Virginia Commonwealth University Health System/Medical College of Virginia Hospitals, Richmond, VA, USA.
authors.forename: Kathryn T
authors.initials: KT
authors.lastname: Maples
authors.affiliation: Virginia Commonwealth University Health System/Medical College of Virginia Hospitals, Richmond, VA, USA denise.lowe@vcuhealth.org.
authors.forename: Denise K
authors.initials: DK
authors.lastname: Lowe
mesh_terms: D000911:Antibodies, Monoclonal / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D018572:Disease-Free Survival; D006801:Humans; D007167:Immunotherapy; D060046:Maintenance Chemotherapy; D009447:Neuroblastoma / Q000188:drug therapy* / Q000276:immunology
chemical_list: D000911:Antibodies, Monoclonal; C112746:dinutuximab
keywords: cancer; formulary; immunology; monoclonal antibodies; pediatric hematology-oncology