Naxitamab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Target | GD2 |
| Clinical data | |
| Trade names | Danyelza |
| Other names | naxitamab-gqgk |
| License data | |
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6414H9910N1718O1996S44 |
| Molar mass | 144436.50 g·mol−1 |
Naxitamab, sold under the brand name Danyelza, is an anti-cancer medication. It is a monoclonal antibody used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for people one year of age and older with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy.[2][3]
The most common adverse reactions include injection site reactions or infusion-related reactions, pain, tachycardia (fast heart beats), vomiting, cough, nausea, diarrhea, decreased appetite, hypertension, fatigue, erythema multiforme, peripheral neuropathy, urticaria, pyrexia, headache, injection site reaction, edema, anxiety, localized edema, and irritability.[2][4]
The U.S. Food and Drug Administration (FDA) granted the application for naxitamab priority review, breakthrough therapy, and, orphan drug designations.[2] The FDA issued a priority review voucher for this rare pediatric disease product application[2] and was later granted a priority approval.[5]
- ^ "Danyelza- naxitamab injection". DailyMed. Retrieved 22 May 2021.
- ^ a b c d "FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow". U.S. Food and Drug Administration (FDA) (Press release). 25 November 2020. Retrieved 25 November 2020. This article incorporates text from this source, which is in the public domain.
- ^ "FDA Approves Y-mAbs' Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma" (Press release). Y-mAbs Therapeutics. 25 November 2020. Retrieved 25 November 2020 – via GlobeNewswire.
- ^ Cite error: The named reference
FDA snapshotwas invoked but never defined (see the help page). - ^ Markham A (February 2021). "Naxitamab: First Approval". Drugs. 81 (2): 291–296. doi:10.1007/s40265-021-01467-4. PMID 33616889. S2CID 231981814.