Dinutuximab

(Unituxin®)

Unituxin®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 17.5 mg/5 mL)
Drug ClassBD2-binding monoclonal antibodies
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Difluoromethylornithine (DFMO) Post-Immunotherapy for High-Risk Neuroblastoma (HRNB): DFMO improved event-free survival (EFS) and overall survival (OS) in HRNB patients post-immunotherapy compared to a control group; EFS (hazard ratio (HR), 0.50 [95% confidence interval (CI), 0.29 to 0.84]; P = .008) and OS (HR, 0.38 [95% CI, 0.19 to 0.76]; P = .007).
  • Dinutuximab Immunotherapy for HRNB: Patients in the dinutuximab immunotherapy group showed higher 5-year survival outcomes than those in the isotretinoin-only group, with a 5-year EFS of 56.6 ± 4.7% vs. 46.1 ± 5.1% (P = 0.042) and a 5-year OS of 73.2 ± 4.2% vs. 56.6 ± 5.1% (P = 0.045).
  • Effectiveness Summary: Both DFMO and dinutuximab demonstrated significant improvements in EFS and OS for HRNB patients, with DFMO showing HRs of 0.50 for EFS and 0.38 for OS, and dinutuximab showing a 10.5% higher 5-year EFS and 16.6% higher 5-year OS compared to isotretinoin-only treatment.
  • There is no safety information available in the reviewed studies for DFMO. For dinutuximab, 13 out of 122 patients developed human anti-chimeric antibodies (HACA), but these did not correlate with event-free or overall survival or with clinically significant toxicity; FC gamma receptor 2A and 3A genotypes similarly showed no correlation with survival or significant toxicity.
  • There is no population types or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Unituxin (dinutuximab) Prescribing Information.2020United Therapeutics Corporation, Silver Spring, MD

Systematic Reviews / Meta-Analyses