Epcoritamab

Epcoritamab
Monoclonal antibody
TypeBi-specific T-cell engager
SourceHumanized
TargetCD3E, CD20
Clinical data
Trade namesEpkinly, Tepkinly
Other namesepcoritamab-bysp, GEN3013
AHFS/Drugs.comMonograph
MedlinePlusa623023
License data
Routes of
administration		Subcutaneous
Drug classAntineoplastic
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6471H9999N1735O2007S44
Molar mass145624.95 g·mol−1

Epcoritamab, sold under the brand name Epkinly, is a monoclonal antibody anticancer medication used for the treatment of diffuse large B-cell lymphoma.[4][7] Epcoritamab is a bispecific CD20-directed CD3 T-cell engager.[4][7] Epcoritamab was co-developed by AbbVie and Genmab.[8]

Epcoritamab was approved for medical use in the United States in May 2023,[4][7][9][8][10][11] in the European Union in September 2023,[6] and in Canada in December 2023.[1]

  1. ^ a b "Epkinly Product information". Health Canada. 22 October 2009. Retrieved 3 March 2024.
  2. ^ "Details for: Epkinly". Health Canada. 18 December 2023. Retrieved 3 March 2024.
  3. ^ "Summary Basis of Decision (SBD) for Epkinly". Drug and Health Products Portal. 1 September 2012. Retrieved 9 May 2024.
  4. ^ a b c d "Epcoritamab-bysp- epcoritamab injection, solution Epcoritamab-bysp- epcoritamab injection, solution, concentrate". DailyMed. 16 May 2023. Archived from the original on 25 May 2023. Retrieved 24 May 2023.
  5. ^ Cite error: The named reference Tepkinly PI was invoked but never defined (see the help page).
  6. ^ a b "Tepkinly EPAR". European Medicines Agency. 5 October 2023. Retrieved 5 October 2023.
  7. ^ a b c "FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma". U.S. Food and Drug Administration (FDA). 19 May 2023. Archived from the original on 23 May 2023. Retrieved 24 May 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  8. ^ a b "Epkinly (epcoritamab-bysp) Approved by U.S. FDA as the First and Only Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)" (Press release). AbbVie. 19 May 2023. Archived from the original on 19 May 2023. Retrieved 20 May 2023 – via PR Newswire.
  9. ^ "FDA approves treatment for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma". U.S. Food and Drug Administration (FDA). 19 May 2023. Archived from the original on 2 June 2023. Retrieved 2 June 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  10. ^ "Drug Approval Package: Epkinly". U.S. Food and Drug Administration (FDA). 26 May 2023. Retrieved 30 May 2023.
  11. ^ Frampton JE (September 2023). "Epcoritamab: First Approval". Drugs. 83 (14): 1331–1340. doi:10.1007/s40265-023-01930-4. PMID 37597091. S2CID 261030074.