Overview
Naxitamab (humanized 3F8, hu3F8) is an IgG1 monoclonal antibody directed against the oncofetal differentiation antigen GD2 disialoganglioside. Normally expressed during fetal development and in mature neurons, pain fibers, and skin cells, GD2 constitutes a highly efficient target in the treatment of neuroblastoma - it is widely expressed across and within neuroblastomas (and other neuroectodermal tumors), and is rarely subject to antigen loss. The first anti-GD2-monoclonal IgG antibody to be approved by the FDA for the treatment of neuroblastoma was dinutuximab under the brand name Unituxin in 2015. One stark disadvantage of this therapy is the requirement for concurrent use of granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA). Naxitamab-gqgk (Danyelza) was granted accelerated approval by the FDA in November 2020 for the treatment of high-risk relapsed/refractory neuroblastoma of the bone or bone marrow. This approval requires naxitamab to be co-administered only with GM-CSF, a factor known to enhance the granulocyte-mediated antibody-dependent cytotoxicity of anti-GD2 therapies, making the administration of naxitamab therapy markedly simpler than that of its predecessor.
Indication
Naxitamab-gqgk is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of patients 1 year of age and older 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.
Associated Conditions
- High risk, refractory Neuroblastomas of the bone or bone marrow
- High risk, relapsed Neuroblastomas of the bone or bone marrow
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/18 | Phase 1 | Recruiting | Steven DuBois, MD | ||
2025/06/09 | Phase 1 | Not yet recruiting | |||
2024/08/07 | Phase 2 | Recruiting | Giselle Sholler | ||
2024/07/30 | Phase 2 | Recruiting | |||
2024/06/03 | Phase 2 | Completed | |||
2023/09/21 | Phase 4 | Not yet recruiting | SciClone Pharmaceuticals | ||
2023/09/07 | Phase 1 | Recruiting | Margaret Gatti-Mays | ||
2023/08/28 | Phase 2 | Recruiting | Sun Yat-sen University | ||
2023/08/01 | Phase 2 | Recruiting | Anna Raciborska | ||
2023/03/06 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Y-mAbs Therapeutics, Inc. | 73042-201 | INTRAVENOUS | 40 mg in 10 mL | 3/31/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Naxitamab Injection | 国药准字SJ20220019 | 生物制品 | 注射剂 | 11/30/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DANYELZA CONCENTRATE FOR SOLUTION FOR INFUSION 40MG/10ML | N/A | N/A | N/A | 7/16/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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