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Naxitamab is a humanised anti-GD2 antibody from Memorial Sloan Kettering, given as an outpatient with GM-CSF for relapsed neuroblastoma in bone or marrow.
Accelerated approval November 2020 for relapsed/refractory high-risk neuroblastoma in bone or bone marrow (Study 201: ORR 50%; MSK 12-230: ORR 45%). Phase 2 in primary refractory disease with stepped-up GM-CSF: 75% CR in a 32-patient series (2025). Outpatient 30-minute infusions but severe pain and hypertension. Y-mAbs.
Humanised 3F8 IgG1 anti-GD2 with higher affinity; ADCC/CDC enhanced by GM-CSF-primed granulocytes. Connects to GD2 (disialoganglioside).
1.Naxitamab binds GD2 (disialoganglioside).
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Mostly paediatric, given in specialist centres.
Paediatric relapsed/refractory neuroblastoma; commercial and Medicaid plans cover on label with prior authorisation.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE search: naxitamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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In combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), 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.
Accelerated approval (Study 201, 12-230) The confirmatory requirement was still open 5.8 years later, when the FDA's table was read.
| Region | Year | Indication |
|---|---|---|
| US | 2020 | Relapsed/refractory high-risk neuroblastoma in bone or bone marrow with partial response, minor response or stable disease, with GM-CSF (accelerated) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Pain | 100% | 65% |
| Hypertension | 42% | 28% |
| Infusion-related reaction | - | 32% |
| Neurotoxicity | 20% | - |
Study 201 / 12-230 pooled. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Naxitamab" OR ABSTRACT:"Naxitamab" OR TITLE:"Danyelza" OR ABSTRACT:"Danyelza") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Naxitamab, not a curated reading list.
Shares Naxitamab Study 201, Neuroblastoma (paediatric), Monoclonal antibodies.
Shares GD2 (disialoganglioside), High-risk neuroblastoma, Neuroblastoma (paediatric), Rare and paediatric cancers without markets.
Shares GD2 (disialoganglioside), High-risk neuroblastoma, Neuroblastoma (paediatric), Rare and paediatric cancers without markets.
Shares GD2 (disialoganglioside), High-risk neuroblastoma, Neuroblastoma (paediatric), Rare and paediatric cancers without markets.
Shares Anti-GD2 antibody + irinotecan-temozolomide (chemoimmunotherapy), GD2 (disialoganglioside), High-risk neuroblastoma, Childhood cancers (all types).
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Shares GD2 (disialoganglioside), Neuroblastoma (paediatric), Monoclonal antibodies.
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