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The antibody that raised cure rates in high-risk childhood neuroblastoma by about 20 points when given after transplant with immune boosters and retinoid.
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).
Chimeric IgG1 anti-GD2; ADCC (NK cells, granulocytes with GM-CSF) and CDC against GD2+ cells; neuropathic pain from binding to peripheral nerve GD2. Connects to GD2 (disialoganglioside).
1.Antibody binds GD2 on the neuroblastoma cell surface
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. Unituxin is usually given inpatient in paediatric centres (Part A / Medicaid); dinutuximab beta (Qarziba) is not FDA-approved.
Paediatric high-risk neuroblastoma; most children are covered by commercial family plans or Medicaid/CHIP, which cover on-label use with review.
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 TA538 · SMC advice: dinutuximab beta. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Unituxin (ANBL0032)
Dinutuximab beta (Qarziba)
| Region | Year | Indication |
|---|---|---|
| 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 |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neuropathic pain | 85% | 52% |
| Infusion reactions | - | 25% |
| Capillary leak syndrome | - | 23% |
| Hypokalaemia | - | 35% |
ANBL0032 immunotherapy arm. 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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Confirms irinotecan-temozolomide-dinutuximab as the reference salvage regimen and motivated frontline chemo-immunotherapy trials (ANBL17P1, ANBL1531).
Chemo-immunotherapy with dinutuximab became the salvage standard for relapsed neuroblastoma and the regimen to move into first-line induction.
Query for this drug: (TITLE:"Dinutuximab ch14.18 / dinutuximab beta" OR ABSTRACT:"Dinutuximab ch14.18 / dinutuximab beta" OR TITLE:"Unituxin" OR ABSTRACT:"Unituxin" OR TITLE:"Qarziba" OR ABSTRACT:"Qarziba") 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 Dinutuximab (ch14.18) / dinutuximab beta, not a curated reading list.
Shares Anti-GD2 antibody + irinotecan-temozolomide (chemoimmunotherapy), GD2 (disialoganglioside), High-risk neuroblastoma, Childhood cancers (all types).
Shares Partner Therapeutics, ANBL1221 expansion: irinotecan, temozolomide and dinutuximab with GM-CSF in refractory or relapsed neuroblastoma, ANBL1221, ANBL17P1.
Shares MIBG Curie and SIOPEN scores, Segmental chromosomal aberrations and ploidy (neuroblastoma), High-risk neuroblastoma, Neuroblastoma (paediatric).
Shares MYCN amplification, Segmental chromosomal aberrations and ploidy (neuroblastoma), High-risk neuroblastoma, Neuroblastoma (paediatric).
Shares GD2 (disialoganglioside), High-risk neuroblastoma, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Neuroblastoma (paediatric).
Shares GD2 (disialoganglioside), High-risk neuroblastoma, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Neuroblastoma (paediatric).
Shares GD2 (disialoganglioside), High-risk neuroblastoma, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Neuroblastoma (paediatric).
Shares Julie R. Park, High-risk neuroblastoma, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Neuroblastoma (paediatric).