Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 17.5 mg/5 mL) |
Drug Class | BD2-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
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Unituxin (dinutuximab) Prescribing Information. | 2020 | United Therapeutics Corp., Research Triangle Park, NC |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Clinical pharmacology of cytotoxic drugs in neonates and infants: Providing evidence-based dosing guidance. | 2022 | European Journal of Cancer |
Commonly reported adverse events associated with pediatric immunotherapy: a systematic review from the Children’s Oncology Group. | 2021 | Journal of Pediatric Oncology Nursing |
Anti-GD2 antibody-containing immunotherapy postconsolidation therapy for people with high-risk neuroblastoma treated with autologous haematopoietic stem cell transplantation. | 2019 | The Cochrane Database of Systematic Reviews |