Drug updated on 5/17/2024
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
- Dinutuximab (Unituxin) is indicated for the treatment of pediatric patients with high-risk neuroblastoma, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA). This is particularly relevant for those who achieve at least a partial response to prior first-line multiagent, multimodality therapy.
- Three systematic reviews/meta-analyses provided insights into the safety and effectiveness of dinutuximab in different contexts, especially concerning pediatric patients with high-risk neuroblastoma.
- Dinutuximab was categorized alongside other drugs like blinatumomab and doxorubicin with grade B evidence level, indicating some pharmacological evidence to guide dosing but not as robust as drugs scored with grade A such as busulfan, carboplatin, cyclophosphamide. This suggests a moderate level of confidence in dinutuximab's dosing for infants.
- Compared to traditional chemotherapeutics used in treating cancer among neonates and infants, dinutuximab has unique therapy-related adverse events which require specific vigilance and management distinct from those expected from chemotherapy treatments.
- In terms of efficacy among high-risk neuroblastoma patients post-autologous HSCT compared to standard therapies, including Unituxin significantly improves survival outcomes despite lacking detailed analysis on adverse events within this context.
- Due emphasis should be given while using this drug effectively among vulnerable groups such as infants or children suffering from high-risk neuroblastomas due to its potential pivotal role in augmenting their chances of survival.
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 |