Dinutuximab

Dinutuximab
Monoclonal antibody
TypeWhole antibody
SourceChimeric (mouse/human)
TargetGD2
Clinical data
Trade namesUnituxin, Qarziba, others
Other namesCh14.18, APN-311
AHFS/Drugs.comMonograph
MedlinePlusa615022
License data
Pregnancy
category
Routes of
administration
Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
IUPHAR/BPS
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6422H9982N1722O2008S48
Molar mass144981.42 g·mol−1

Dinutuximab (Ch14.18, tradename Unituxin) and dinutuximab beta (tradename Qarziba) are monoclonal antibodies used as a second-line treatment for children with high-risk neuroblastoma. Each antibody is made of both mouse and human components and targets glycolipid GD2, expressed on neuroblastoma cells and on normal cells of neuroectodermal origin, including the central nervous system and peripheral nerves. They differ in that dinutuximab is manufactured using mouse cells, and dinutuximab beta is manufactured using hamster cells. The dosing regime differs, and dinutuximab is given in combination with granulocyte-macrophage colony stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), while dinutuximab beta can be given alone.

They both cause severe side effects, including severe pain that must be controlled with morphine, and a high risk of infusion reaction that must be controlled with antihistamines and anti-inflammatory drugs. They both work by binding to neurons and causing the body's immune system to destroy them.

Dinutuximab received marketing approval in the US and in the European Union in March 2015;[6][7] the marketing approval was withdrawn in 2017.[7] Dinutuximab beta received marketing approval in Europe in 2017.[5] The antibody was originally called Ch14.18 and was discovered by a group at University of California San Diego led by Alice Yu; this antibody and several others were brought into clinical trials funded by the National Cancer Institute.

  1. ^ a b "Qarziba Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 11 April 2020. Retrieved 16 August 2020.
  2. ^ "Summary Basis of Decision (SBD) for Unituxin". Health Canada. 23 October 2014. Retrieved 29 May 2022.
  3. ^ "Qarziba (Dinutuximab beta) 4.5 mg/mL concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 27 November 2019. Retrieved 16 August 2020.
  4. ^ Cite error: The named reference USlabel was invoked but never defined (see the help page).
  5. ^ a b "Qarziba EPAR". European Medicines Agency. 17 September 2018. Retrieved 16 August 2020.
  6. ^ "Unituxin (dinutuximab)". U.S. Food and Drug Administration (FDA). 8 April 2015. Archived from the original on January 7, 2016. Retrieved 16 August 2020.
  7. ^ a b "Unituxin EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 16 August 2020.