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Qarziba
Published
Product name
Qarziba
Active ingredient
Dinutuximab beta
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Qarziba (dinutuximab beta) was approved for the following therapeutic use:
Qarziba is indicated for the treatment of high-risk neuroblastoma in patients who have previously received induction chemotherapy and achieved at least a partial response.
How this medicine works
Dinutuximab beta is a chimeric monoclonal IgG1 antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells.Dinutuximab beta has been shown in vitro to bind to neuroblastoma cell lines known to express GD2 and to induce both complement dependent cytotoxicity (CDC) and antibody dependent cell-mediated cytotoxicity (ADCC). In the presence of human effector cells, including peripheral blood mononuclear cells from normal human donors, dinutuximab beta was found to mediate the lysis of human neuroblastoma and melanoma cell lines expressing GD2 in a dose dependent manner. Additionally, in vivo studies demonstrated that dinutuximab beta could suppress liver metastasis in a syngeneic liver metastasis mouse model.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Qarziba was considered favourable for the therapeutic use approved.
Sponsor