Overview
Dinutuximab is an IgG1 monoclonal human/mouse chimeric antibody against GD2, a disialoganglioside expressed on tumors of neuroectodermal origin, including human neuroblastoma and melanoma, with highly restricted expression on normal tissues. It is composed of the variable heavy- and light-chain regions of the murine anti-GD2 mAb 14.18 and the constant regions of human IgG1 heavy-chain and kappa light-chain. By binding to GD2, dinutiximab induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity of tumor cells thereby leading to apoptosis and inhibiting proliferation of the tumour. It is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Despite a high clinical response seen after first-line treatment, the complete eradication of neuroblastoma is rarely achieved and the majority of patients with advanced disease suffer a relapse. Current strategies for treatment include immunotherapy with drugs such as dinutuximab to target surviving neuroblastoma cells and to prevent relapse.
Indication
Dinutuximab is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Despite a high clinical response seen after first-line treatment, the complete eradication of neuroblastoma is rarely achieved and the majority of patients with advanced disease suffer a relapse. Current strategies for treatment include immunotherapy with drugs such as dinutuximab to target surviving neuroblastoma cells and to prevent relapse.
Associated Conditions
- High Risk Neuroblastoma
Research Report
Dinutuximab (DB09077): A Comprehensive Monograph on its Pharmacology, Clinical Efficacy, and Role in the Treatment of High-Risk Neuroblastoma
Executive Summary
Dinutuximab represents a landmark therapeutic advancement in pediatric oncology, establishing immunotherapy as a cornerstone in the management of high-risk neuroblastoma.[1] As the first agent of its class approved for this indication, it fundamentally altered the treatment landscape for a disease with a historically poor prognosis. The drug is a chimeric monoclonal antibody that targets the disialoganglioside GD2, an antigen highly expressed on neuroblastoma cells. Its mechanism of action involves the recruitment of host immune effector mechanisms—namely, antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC)—to induce potent and specific lysis of tumor cells.[3]
The clinical value of Dinutuximab was unequivocally established in the pivotal, randomized ANBL0032 trial conducted by the Children's Oncology Group. The addition of Dinutuximab to standard post-consolidation therapy resulted in a statistically significant and clinically meaningful improvement in both event-free survival (EFS) and overall survival (OS).[5] The magnitude of this benefit was so profound that the trial was terminated early, cementing the drug's role as a standard of care.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/21 | Phase 1 | Not yet recruiting | Prof. Dr. Dirk Reinhardt | ||
2024/11/01 | Phase 3 | Recruiting | N.N. Petrov National Medical Research Center of Oncology | ||
2024/07/03 | Phase 1 | Recruiting | Princess Maxima Center for Pediatric Oncology | ||
2024/06/10 | Phase 2 | Active, not recruiting | New Approaches to Neuroblastoma Therapy Consortium | ||
2023/12/15 | Phase 3 | Recruiting | |||
2023/03/06 | Phase 2 | Recruiting | |||
2022/09/28 | Phase 2 | Suspended | Prof. Franca Fagioli | ||
2022/06/16 | Not Applicable | Recruiting | |||
2022/05/13 | Phase 1 | Completed | |||
2021/10/18 | Phase 2 | Completed | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| United Therapeutics Corporation | 66302-014 | INTRAVENOUS | 3.5 mg in 1 mL | 9/30/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/8/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| QARZIBA CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/4.5ML | N/A | N/A | N/A | 11/20/2020 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| QARZIBA dinutuximab beta 4.5 mg/mL concentrate for solution for infusion, 20 mg/4.5 mL vial | 321016 | Medicine | A | 4/2/2020 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| UNITUXIN | 02483076 | Solution - Intravenous | 3.5 MG / ML | 5/1/2019 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| QARZIBA 4,5 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION | 1171191001 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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