PURPOSE: The pharmacology, clinical efficacy, safety, dosage and administration, 
and role in therapy of dinutuximab for the treatment of high-risk pediatric 
neuroblastoma are reviewed.
SUMMARY: Dinutuximab (Unituxin, United Therapeutics) is a novel monoclonal 
antibody recently approved for use in combination with granulocyte- macrophage 
colony-stimulating factor, interleukin-2, and isotretinoin for the treatment of 
pediatric patients with high-risk neuroblastoma. Its approval has led to the 
first major change in standard recommended first-line maintenance therapy for 
high-risk pediatric neuroblastoma in over a decade. Dinutuximab causes 
antibody-dependent cell-mediated cytotoxicity and complement-dependent 
cytotoxicity by binding to GD2, a tumor-associated antigen. The recommended 
dosage of dinutuximab is 17.5 mg/m2/day for 4 consecutive days of each 24- or 
32-day cycle, for a maximum of 5 cycles. In a Phase III trial, patients who 
received dinutuximab as part of combination immunotherapy in addition to 
standard maintenance therapy had significantly improved 2-year event-free 
survival relative to those who received standard maintenance therapy alone (66% 
versus 46%, p < 0.01). Dinutuximab has a unique adverse-effect profile that 
includes infusion reactions, neuropathic pain, and electrolyte abnormalities; 
the most common adverse effects observed with dinutuximab use in clinical trials 
were pain, pyrexia, myelosuppression, infusion reactions, and electrolyte 
abnormalities.
CONCLUSION: Dinutuximab is a novel monoclonal antibody that is efficacious as 
part of combination immunotherapy in pediatric patients with high-risk 
neuroblastoma.