Naxitamab
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.
- Route
- IV over 30-60 minutes (outpatient)
- Schedule
- 3 mg/kg days 1, 3, 5 of each 4-week cycle with GM-CSF days -4 to 5; premedication with antihistamine, antipyretic, gabapentin, opioids
- Monitoring
- Pain, hypertension (including delayed), infusion reactions, neurotoxicity (transverse myelitis, RPLS), hypotension
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: naxitamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 25 Nov 2020ApprovalUS
Accelerated approval (Study 201, 12-230)
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
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