Dinutuximab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Chimeric (mouse/human) |
| Target | GD2 |
| Clinical data | |
| Trade names | Unituxin, Qarziba, others |
| Other names | Ch14.18, APN-311 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a615022 |
| License data |
|
| Pregnancy category |
|
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| IUPHAR/BPS | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C6422H9982N1722O2008S48 |
| Molar mass | 144981.42 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Dinutuximab received marketing approval in the US and in the European Union in March 2015; the marketing approval was withdrawn in 2017. Dinutuximab beta received marketing approval in Europe in 2017. 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.