Summary

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• Unituxin (dinutuximab) is 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.
• This summary is based on the review of three systematic review(s)/meta-analysis(es). ^[1-3]
• In people with high-risk neuroblastoma pre-treated with autologous hematopoietic stem cell transplantation (HSCT), dinutuximab-containing immunotherapy demonstrated improved overall survival (HR 0.50, 95% CI 0.31 to 0.80; P = 0.004) and event-free survival (HR 0.61, 95% CI 0.41 to 0.92; P = 0.020) compared to standard therapy.
• Dinutuximab has some pharmacological evidence supporting its dosing in infants, graded as B, indicating moderate support compared to other drugs such as busulfan and carboplatin, which received a grade A for their dosing evidence.
• The review emphasized the importance of understanding the unique adverse event profiles associated with dinutuximab, though specific adverse events were not detailed in the study.
• Randomized data on adverse events specific to dinutuximab were not reported, and therefore, no detailed safety concerns could be identified.
• The evidence supports the effectiveness of dinutuximab in improving overall survival and event-free survival in pediatric patients with high-risk neuroblastoma pre-treated with autologous HSCT, with specific pharmacological evidence available for dosing in infants (grade B); however, safety data specific to these subgroups are not detailed.