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
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 | Phase 4 | Suspended | |||
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 |
---|---|---|---|---|---|
Dinutuximab beta Injection | 国药准字SJ20210023 | 生物制品 | 注射剂 | 8/12/2021 |
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 |
Help Us Improve
Your feedback helps us provide better drug information and insights.