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Dinutuximab

Generic Name
Dinutuximab
Brand Names
Unituxin, Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
Drug Type
Biotech
CAS Number
1363687-32-4
Unique Ingredient Identifier
7SQY4ZUD30

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

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

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