# Dinutuximab (ch14.18) / dinutuximab beta

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

## TL;DR

The antibody that raised cure rates in high-risk childhood neuroblastoma by about 20 points when given after transplant with immune boosters and retinoid.

## Summary

ANBL0032: ch14.18 + GM-CSF + IL-2 + isotretinoin vs isotretinoin: 2-year EFS 66% vs 46%, OS 86% vs 75%; approved March 2015 (United Therapeutics). Dinutuximab beta (SIOPEN/EUSA/Recordati) approved in EU 2017; HR-NBL1 showed adding IL-2 to dinutuximab beta added toxicity without benefit, so IL-2 is omitted in Europe. Now also given with chemotherapy for relapse (ANBL1221: irinotecan-temozolomide-dinutuximab ORR ~50%) and during induction (ANBL17P1).

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Unituxin / Qarziba (EU)
- Modality: Monoclonal antibody (anti-GD2, chimeric)
- Mechanism: Chimeric IgG1 anti-GD2; ADCC (NK cells, granulocytes with GM-CSF) and CDC against GD2+ cells; neuropathic pain from binding to peripheral nerve GD2.
- Approvals: US 2015: High-risk neuroblastoma after at least partial response to induction, with GM-CSF, IL-2 and isotretinoin; EU 2017: Dinutuximab beta: high-risk neuroblastoma after induction/transplant; relapsed/refractory disease
- Dosing: IV; 17.5 mg/m2/day × 4 days per cycle, 5 cycles, with GM-CSF (cycles 1, 3, 5) and isotretinoin; IL-2 omitted in European practice
- Toxicity (grade 3+): Neuropathic pain 52%; Infusion reactions 25%; Capillary leak syndrome 23%; Hypokalaemia 35%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Dinutuximab
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Dinutuximab/%20dinutuximab%20beta

## 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: [Partner Therapeutics](https://onco.cc/companies/partner-therapeutics/), [United Therapeutics](https://onco.cc/companies/united-therapeutics/)
- terms: [ADCC (antibody-dependent cellular cytotoxicity)](https://onco.cc/terms/adcc/), [MIBG Curie and SIOPEN scores](https://onco.cc/terms/curie-siopen-score/), [Segmental chromosomal aberrations and ploidy (neuroblastoma)](https://onco.cc/terms/segmental-chromosomal-aberrations/)
- trials: [ANBL1221](https://onco.cc/trials/anbl1221/), [ANBL17P1](https://onco.cc/trials/anbl17p1/), [COG ANBL0032](https://onco.cc/trials/anbl0032/), [High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)](https://onco.cc/trials/nct04221035/), [SIOPEN HR-NBL1](https://onco.cc/trials/hr-nbl1/)
- pairings: [Anti-GD2 antibody + irinotecan-temozolomide (chemoimmunotherapy)](https://onco.cc/pairings/anti-gd2-plus-chemo-relapse/), [Caution: IL-2 added to anti-GD2 therapy](https://onco.cc/pairings/il2-anti-gd2-caution/)
- people: [Alice L. Yu](https://onco.cc/people/alice-yu/), [Julie R. Park](https://onco.cc/people/julie-park/)
- bottlenecks: [Rare and paediatric cancers without markets](https://onco.cc/bottlenecks/b-rare-cancers/)
- institutions: [UC San Diego Moores Cancer Center](https://onco.cc/institutions/ucsd-moores/), [University of Wisconsin Carbone Cancer Center](https://onco.cc/institutions/uw-carbone/)
- biomarkers: [MYCN amplification](https://onco.cc/biomarkers/mycn-amp/)
- roadmaps: [Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first](https://onco.cc/roadmaps/paediatric-oncology-roadmap/)
- drugs: [Isotretinoin](https://onco.cc/drugs/isotretinoin/)
- key papers: [ANBL1221 expansion: irinotecan, temozolomide and dinutuximab with GM-CSF in refractory or relapsed neuroblastoma](https://onco.cc/key-papers/paper-anbl1221-expansion-dinutuximab-gm-csf-mody-jco-2020/), [ANBL1221: irinotecan-temozolomide with temsirolimus or dinutuximab in relapsed or refractory neuroblastoma](https://onco.cc/key-papers/paper-anbl1221-irinotecan-temozolomide-dinutuximab-mody-lancet-oncol-2017/)

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