# Naxitamab

Source: https://onco.cc/drugs/naxitamab/  
OnCo record `naxitamab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Danyelza
- Modality: Monoclonal antibody (anti-GD2, humanised)
- Mechanism: Humanised 3F8 IgG1 anti-GD2 with higher affinity; ADCC/CDC enhanced by GM-CSF-primed granulocytes.
- Approvals: US 2020: Relapsed/refractory high-risk neuroblastoma in bone or bone marrow with partial response, minor response or stable disease, with GM-CSF (accelerated)
- Dosing: IV over 30-60 minutes (outpatient); 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
- Toxicity (grade 3+): Pain 65%; Hypertension 28%; Infusion-related reaction 32%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Naxitamab
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Naxitamab

## Connected records

- cancers: [Childhood cancers (all types)](https://onco.cc/cancers/childhood-cancers/), [High-risk neuroblastoma](https://onco.cc/cancers/neuroblastoma-high-risk/), [Neuroblastoma (paediatric)](https://onco.cc/cancers/neuroblastoma/)
- technologies: [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [GD2 (disialoganglioside)](https://onco.cc/targets/gd2/)
- companies: [Y-mAbs Therapeutics](https://onco.cc/companies/y-mabs/)
- trials: [Naxitamab Study 201](https://onco.cc/trials/naxitamab-201/), [Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)](https://onco.cc/trials/nct07011654/)
- pairings: [Anti-GD2 antibody + irinotecan-temozolomide (chemoimmunotherapy)](https://onco.cc/pairings/anti-gd2-plus-chemo-relapse/)
- bottlenecks: [Rare and paediatric cancers without markets](https://onco.cc/bottlenecks/b-rare-cancers/)

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