 | |
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | CD38 |
| Clinical data | |
| Trade names | Darzalex, Darzalex SC |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a616002 |
| License data |
|
| Pregnancy category |
|
| Routes of administration | Intravenous, subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C6466H9996N1724O2010S42 |
| Molar mass | 145391.67 g·mol−1 |
  (what is this?) (verify) | |
Daratumumab, sold under the brand name Darzalex among others, is an anti-cancer monoclonal antibody medication. It binds to CD38,[7] which is overexpressed in multiple myeloma cells.[8] Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab.[9]
Daratumumab was granted breakthrough therapy drug status in 2013, for multiple myeloma. It was granted orphan drug status for multiple myeloma, diffuse large B cell lymphoma, follicular lymphoma, and mantle cell lymphoma.[10]
It is available in combination with hyaluronidase as daratumumab/hyaluronidase (brand name Darzalex Faspro).[11][12]
- ^ "Prescription medicines: registration of new chemical entities in Australia, 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 9 April 2023.
- ^ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 31 March 2024.
- ^ "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
- ^ "Darzalex SC Product information". Health Canada. 12 August 2020. Retrieved 24 June 2024.
- ^ "Darzalex- daratumumab injection, solution, concentrate Darzalex IV- daratumumab injection, solution, concentrate". DailyMed. Retrieved 18 December 2021.
- ^ "Darzalex EPAR". European Medicines Agency (EMA). 17 July 2013. Retrieved 21 September 2024.
- ^ World Health Organization (2009). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 101" (PDF). WHO Drug Information. 23 (2). Archived from the original (PDF) on 17 December 2010.
- ^ Lokhorst HM, Plesner T, Laubach JP, Nahi H, Gimsing P, Hansson M, et al. (September 2015). "Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma". The New England Journal of Medicine. 373 (13): 1207–1219. doi:10.1056/NEJMoa1506348. hdl:1874/331934. PMID 26308596.
- ^ "Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab". Janssen Biotech. Retrieved 31 January 2013.
- ^ "Daratumumab Receives Breakthrough Therapy Designation from US Food and Drug Administration". Genmab A/S. 1 May 2013. Archived from the original on 13 January 2017. Retrieved 10 January 2017.
- ^ "FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma". U.S. Food and Drug Administration (FDA) (Press release). 1 May 2020. Retrieved 1 May 2020.
This article incorporates text from this source, which is in the public domain.
- ^ "Genmab Announces U.S. FDA Approval of Subcutaneous Formulation of Daratumumab, Darzalex Faspro (daratumumab and hyaluronidase-fihj), for the Treatment of Patients with Multiple Myeloma" (Press release). Genmab. 1 May 2020. Retrieved 1 May 2020 – via GlobeNewswire.
