Dinutuximab (ch14.18) / dinutuximab beta
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).
1.Antibody binds GD2 on the neuroblastoma cell surface
- Route
- IV
- Schedule
- 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
- Dose modifications
- Hold for grade 3-4 infusion reactions, capillary leak, neuropathy
- Monitoring
- Pain management (opioids, gabapentin), hypotension, capillary leak, infusion reactions, neuropathy, electrolytes
- 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. Unituxin is usually given inpatient in paediatric centres (Part A / Medicaid); dinutuximab beta (Qarziba) is not FDA-approved.
- Commercial insurance
- covered with prior authorisation
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.
- Appraised for
- High-risk neuroblastoma after induction, high-dose chemotherapy and stem cell transplant, or relapsed/refractory
- Notes
- Dinutuximab (Unituxin) is US-only; dinutuximab beta (Qarziba) is the UK product.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA538 · SMC advice: dinutuximab beta. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 10 Mar 2015ApprovalUS
Unituxin (ANBL0032)
- May 2017ApprovalEU
Dinutuximab beta (Qarziba)
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductNaxitamab
Shares Anti-GD2 antibody + irinotecan-temozolomide (chemoimmunotherapy), GD2 (disialoganglioside), Monoclonal antibodies, Neuroblastoma (paediatric).
- CompanyY-mAbs Therapeutics
Shares GD2 (disialoganglioside), Neuroblastoma (paediatric), Rare and paediatric cancers without markets.
- IdeaGD2 CAR-T as consolidation in high-risk neuroblastoma
Shares GD2 (disialoganglioside), Neuroblastoma (paediatric), Rare and paediatric cancers without markets.
- InstitutionChildren's Oncology Group (COG)
Shares COG ANBL0032, Alice L. Yu, Julie R. Park, University of Wisconsin Carbone Cancer Center.
- InstitutionSt. Jude Children's Research Hospital
Shares Julie R. Park, Neuroblastoma (paediatric), Rare and paediatric cancers without markets.
- InstitutionSIOP Europe – European Society for Paediatric Oncology
Shares SIOPEN HR-NBL1, Neuroblastoma (paediatric), Rare and paediatric cancers without markets.
- TrialGD2-CART01 (Bambino Gesù phase 1/2)
Shares GD2 (disialoganglioside), Neuroblastoma (paediatric), Rare and paediatric cancers without markets.
- TrialCOG ANBL0532
Shares Julie R. Park, Neuroblastoma (paediatric).