Dinutuximab (Unituxin)

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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

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  • 2017-03-20: Authorization withdrawn at the request of the manufacturer, for supply chain reasons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