Drug updated on 4/26/2024
| Dosage Form | Injection (intravenous: 40 mg/10 mL (4 mg/mL)) |
| Drug Class | GD2-binding monoclonal antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated, in combination with granulocyte-macrophage colony-stimulating factor (GMCSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Danyelza (naxitamab-gqgk) Prescribing Information. | 2024 | Y-mAbs Therapeutics, Inc., New York, NY |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Outpatient administration of naxitamab in combination with granulocyte-macrophage colony-stimulating factor in patients with refractory and/or relapsed high-risk neuroblastoma: Management of adverse events. | Data not availableSubjects F: null% M: null% | 2023 | Cancer Reports |
| Naxitamab, a new generation anti-GD2 monoclonal antibody (mAb) for treatment of relapsed/refractory high-risk neuroblastoma (HR-NB). | Data not availableSubjects F: null% M: null% | 2020 | Journal of Clinical Oncology |
| Survival impact of anti-gd2 antibody response in a phase II ganglioside vaccine trial among patients with high-risk neuroblastoma with prior disease progression. | Data not availableSubjects F: null% M: null% | 2020 | Journal of Clinical Oncology |
Sex Distribution:
Year:
2023
Source:Cancer Reports
Sex Distribution:
Year:
2020
Source:Journal of Clinical Oncology
Sex Distribution:
Year:
2020
Source:Journal of Clinical Oncology