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Daratumumab information


Daratumumab
Fab fragment of daratumumab (teal/green) binding CD38 (pale pink). From PDB entry 7DHA
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetCD38
Clinical data
Trade namesDarzalex
AHFS/Drugs.comMonograph
MedlinePlusa616002
License data
  • US DailyMed: Daratumumab
Pregnancy
category
  • AU: C
Routes of
administration
Intravenous
ATC code
  • L01FC01 (WHO)
Legal status
Legal status
  • AU: S4 (Prescription only)[1][2]
  • CA: ℞-only[3]
  • UK: POM (Prescription only)
  • US: ℞-only[4]
  • EU: Rx-only
Identifiers
CAS Number
  • 945721-28-8 ☒N
DrugBank
  • DB09331 checkY
ChemSpider
  • none
UNII
  • 4Z63YK6E0E
KEGG
  • D10777 ☒N
ChEMBL
  • ChEMBL1743007
Chemical and physical data
FormulaC6466H9996N1724O2010S42
Molar mass145391.67 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Daratumumab, sold under the brand name Darzalex, is an anti-cancer monoclonal antibody medication. It binds to CD38,[5] which is overexpressed in multiple myeloma cells.[6] 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.[7]

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.[8]

  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- daratumumab injection, solution, concentrate Darzalex IV- daratumumab injection, solution, concentrate". DailyMed. Retrieved 18 December 2021.
  5. ^ 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 December 17, 2010.
  6. ^ 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.
  7. ^ "Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab". Janssen Biotech. Retrieved 2013-01-31.
  8. ^ "Daratumumab Receives Breakthrough Therapy Designation from US Food and Drug Administration". Genmab A/S. 1 May 2013. Archived from the original on 2017-01-13. Retrieved 2017-01-10.

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Daratumumab

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Daratumumab, sold under the brand name Darzalex, is an anti-cancer monoclonal antibody medication. It binds to CD38, which is overexpressed in multiple...

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cancer (Seagen) Marketed by partners: Darzalex (IV) (daratumumab) / Darzalex Faspro (SC) (daratumumab and hyaluronidase) for the treatment of all stages...

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marker in leukemia. Daratumumab (Darzalex) which targets CD38 has been used in treating multiple myeloma. The use of Daratumumab can interfere with pre-blood...

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daratumumab is in the recognition of the different amino acid groups. Isatuximab identifies 23 amino acids of CD38 to the contrary with daratumumab who...

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groupings include one or more of a monoclonal antibody (e.g., isatuximab or daratumumab), an immunomodulatory agent (e.g., lenalidomide or pomalidomide), and...

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Hyaluronidase

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(Rituxan Hycela), trastuzumab/hyaluronidase-oysk (Herceptin Hylecta), daratumumab/hyaluronidase-fihj (Darzalex Faspro), and pertuzumab/trastuzumab/hyaluronidase–zzxf...

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symptoms of the TEMPI syndrome was reported with the drugs bortezomib, daratumumab and autologous stem cell transplantation. In 2010, the case of a man...

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Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma" at ClinicalTrials.gov Clinical trial...

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combination of bortezomib and dexamethasone is now in widespread clinical use. Daratumumab, a monoclonal antibody to CD38, a protein that is expressed on plasma...

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McCudden, C. (2016). "Monitoring multiple myeloma patients treated with daratumumab: teasing out monoclonal antibody interference". Clin Chem Lab Med. 54...

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dosages, safety, and efficacy of adding daratumumab to the EPOCH regimen in treating patients with PBL. Daratumumab is a prepared monoclonal antibody that...

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are being tested in multiple myeloma and non-Hodgkin's lymphoma e.g. Daratumumab or Celgene's MOR202. CD39 Also known as Ectonucleoside triphosphate diphosphohydrolase...

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soft-tissue sarcoma Nivolumab Bristol-Myers Squibb head and neck cancer Daratumumab Janssen multiple myeloma Rucaparib Clovis Oncology BRCA-mutated ovarian...

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Cardiac amyloidosis

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normal cell lines. There are newer medications (ixazomib, carfilzomib, daratumumab, elotuzumab) under research for the treatment of multiple myeloma that...

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ATC code L01

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L01FB01 Inotuzumab ozogamicin L01FB02 Moxetumomab pasudotox L01FC01 Daratumumab L01FC02 Isatuximab L01FD01 Trastuzumab L01FD02 Pertuzumab L01FD03 Trastuzumab...

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5/27/2016 subcutaneous humanized IL2R Multiple sclerosis 761029 Link daratumumab Darzalex Janssen Biotech 11/16/2015 intravenous fully human CD38 Multiple...

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carfilzomib, lenalidomide, pomalidomide, and a monoclonal antibody (daratumumab or isatuximab); nearly all had also undergone hematopoietic stem cell...

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Monoclonal gammopathy of renal significance

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The monoclonal antibody against the plasma cell surface protein CD38 daratumumab may also be used with very high efficacy against AL amyloidosis. B-cell...

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myeloma] seem promising, such as monoclonal antibodies (anti-CD38 — daratumumab or anti-CS1 — elotuzumab) or the kinesin protein inhibitor Arry-520."...

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