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Epcoritamab

From Wikipedia, the free encyclopedia

Epcoritamab
Monoclonal antibody
TypeBi-specific T-cell engager
SourceHumanized
TargetCD3E, CD20
Clinical data
Trade namesEpkinly, Tepkinly
Other namesGEN3013, epcoritamab-bysp
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,[7][9][8][10][11] in the European Union in September 2023,[6] and in Canada in December 2023.[1]

Medical uses

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Epcoritamab is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including diffuse large B-cell lymphoma arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.[4][7][9]

In June 2024, the US Food and Drug Administration (FDA) expanded the indication to include the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.[12][13]

Side effects

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The US Food and Drug Administration (FDA) prescribing information includes a boxed warning for serious or fatal cytokine release syndrome and immune effector cell-associated neurotoxicity.[12] Warnings and precautions include serious infections and cytopenias.[12]

The most common adverse reactions include cytokine release syndrome, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea.[7]

History

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Epcoritamab was evaluated in the EPCORE NHL-1 (NCT03625037) trial in 148 participants with relapsed or refractory B-cell lymphoma after two or more lines of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy.[7]

For the treatement of follicular lymphoma, the efficacy and safety were evaluated in EPCORE NHL-1 (Study GCT3013-01; NCT03625037), an open-label, multi-cohort, multicenter, single-arm trial that included 127 participants with relapsed or refractory FL after at least two lines of systemic therapy.[12] The primary efficacy and safety were based on 127 participants who received a two step-up dosing regimen.[12] A separate dose optimization cohort of 86 participants evaluated the recommended 3-step up dosage schedule for cytokine release syndrome mitigation.[12]

The US Food and Drug Administration (FDA) granted the application for epcoritamab for follicular lymphoma priority review and breakthrough therapy designations.[12]

Society and culture

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In July 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended a conditional marketing authorization for epcoritamab (Tepkinly).[14] It was approved for medical use in the European Union in September 2023.[5] The EMA granted orphan drug designation to epcoritamab in both February and June 2022.[15][16][17]

Names

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Epcoritamab is the international nonproprietary name.[18][19]

References

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  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. ^ a b "Tepkinly Product information". Union Register of medicinal products. 25 September 2023. Retrieved 1 October 2023.
  6. ^ a b "Tepkinly EPAR". European Medicines Agency. 5 October 2023. Retrieved 5 October 2023.
  7. ^ a b c d e f "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. ^ a b "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.
  12. ^ a b c d e f g "FDA grants accelerated approval to epcoritamab-bysp". U.S. Food and Drug Administration (FDA). 26 June 2024. Retrieved 6 December 2024.
  13. ^ "Cancer Accelerated Approvals". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 6 December 2024.
  14. ^ "Tepkinly: Pending EC decision". European Medicines Agency (EMA). 21 July 2023. Archived from the original on 1 October 2023. Retrieved 1 October 2023.
  15. ^ "EU/3/22/2581: Orphan designation for the treatment of diffuse large B-cell lymphoma". European Medicines Agency (EMA). 21 July 2023. Retrieved 1 October 2023.
  16. ^ "EU/3/22/2634: Orphan designation for the treatment of follicular lymphoma". European Medicines Agency (EMA). 10 May 2023. Retrieved 1 October 2023.
  17. ^ "EU/3/22/2581". Union Register of medicinal products. 25 September 2023. Retrieved 1 October 2023.
  18. ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.
  19. ^ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information. 36 (3). hdl:10665/363551.

Further reading

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  • Clinical trial number NCT03625037 for "First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma (EPCORE NHL-1)" at ClinicalTrials.gov
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