Dinutuximab (Unituxin)
Mechanism of action
From the NCI drug dictionary: A chimeric mouse/human monoclonal antibody with potential antineoplastic activity. Dinutuximab binds to the ganglioside GD2 and induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity against GD2-expressing tumor cells.
Route: IV
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.
Diseases for which it is used
History of changes in FDA indication
- 2015-03-10: Initial FDA approval 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. (Based on COG ANBL0032)
History of changes in EMA indication
- 2015-08-14: Initial authorization for the treatment of high risk neuroblastoma.
- 2017-03-20: Authorization withdrawn at the request of the manufacturer, for supply chain reasons
History of changes in Health Canada indication
- 2018-11-29: Initial notice of compliance
History of changes in PMDA indication
- 2021-06-23: Initial approval for the treatment of neuroblastoma following high-dose chemotherapy.
Patient Drug Information
Also known as
- Code names: Ch14.18, MOAB Ch14.18, monoclonal antibody Ch14.18
- Brand name: Unituxin