Daratumumab

Daratumumab
	Fab fragment of daratumumab (teal/green) binding CD38 (pale pink). From PDB entry 7DHA
Monoclonal antibody
Type	Whole antibody
Source	Human
Target	CD38
Clinical data
Trade names	Darzalex, Darzalex SC
AHFS/Drugs.com	Monograph
MedlinePlus	a616002
License data	US DailyMed: Daratumumab;
Pregnancy; category	AU: C; ;
Routes of; administration	Intravenous, subcutaneous
ATC code	L01FC01 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only); CA: ℞-only / Schedule D; UK: POM (Prescription only); US: ℞-only; EU: Rx-only;
Identifiers
CAS Number	945721-28-8 ;
DrugBank	DB09331 ;
ChemSpider	none;
UNII	4Z63YK6E0E;
KEGG	D10777 ;
ChEMBL	ChEMBL1743007;
Chemical and physical data
Formula	C6466H9996N1724O2010S42
Molar mass	145391.67 g·mol−1
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Daratumumab, sold under the brand name Darzalex among others, is an anti-cancer monoclonal antibody medication. It binds to CD38,^[6] which is overexpressed in multiple myeloma cells.^[7] 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.^[8]

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.^[9]

^ "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.
^ 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.

[1] "Prescription medicines: registration of new chemical entities in Australia, 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 9 April 2023.

[2] "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 31 March 2024.

[3] "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.

[4] "Darzalex SC Product information". Health Canada. 12 August 2020. Retrieved 24 June 2024.

[Darzalex_FDA_label-5] "Darzalex- daratumumab injection, solution, concentrate Darzalex IV- daratumumab injection, solution, concentrate". DailyMed. Retrieved 18 December 2021.

[6] 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.

[Lokhorst2015-7] 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.

[8] "Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab". Janssen Biotech. Retrieved 31 January 2013.

[9] "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.

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