Epcoritamab Explained

Type:mab
Mab Type:BiTE
Source:zu
Target:CD3E, CD20
Tradename:Epkinly, Tepkinly
Dailymedid:Epcoritamab
Routes Of Administration:Subcutaneous
Class:Antineoplastic
Atc Prefix:L01
Atc Suffix:FX27
Legal Ca:Rx-only
Legal Ca Comment:/Schedule D[1] [2] [3]
Legal Us:Rx-only
Legal Us Comment:[4]
Legal Eu:Rx-only
Legal Eu Comment:[5]
Cas Number:2134641-34-0
Drugbank:DB16672
Unii:D6OMY2L0WA
Kegg:D12368
Synonyms:epcoritamab-bysp, GEN3013
C:6471
H:9999
N:1735
O:2007
S:44

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

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

Medical uses

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.

Side effects

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

History

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.

The efficacy outcome measure was overall response rate (ORR), which was 61%. Of those patients, 38% of patients achieved complete response.

Society and culture

Legal status

In July 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended a conditional marketing authorization for epcoritamab (Tepkinly).[11] It was approved for medical use in the European Union in September 2023.[12] The EMA granted orphan drug designation to epcoritamab in both February and June 2022.[13] [14] [15]

Names

Epcoritamab is the international nonproprietary name.[16] [17]

Further reading

Notes and References

  1. Web site: Epkinly Product information . . 22 October 2009 . 3 March 2024.
  2. Web site: Details for: Epkinly . . 18 December 2023 . 3 March 2024.
  3. Web site: Summary Basis of Decision (SBD) for Epkinly . Drug and Health Products Portal . 1 September 2012 . 9 May 2024.
  4. Web site: Epcoritamab-bysp- epcoritamab injection, solution Epcoritamab-bysp- epcoritamab injection, solution, concentrate . DailyMed . 16 May 2023 . 24 May 2023 . 25 May 2023 . https://web.archive.org/web/20230525015647/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7836711-b677-412d-bf2d-0f7c8444103a . live .
  5. Web site: Tepkinly EPAR . European Medicines Agency . 5 October 2023 . 5 October 2023.
  6. Web site: 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 . 24 May 2023 . 23 May 2023 . https://web.archive.org/web/20230523183648/http://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b-cell . live .
  7. Web site: 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 . 2 June 2023 . 2 June 2023 . https://web.archive.org/web/20230602061019/https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-and-high-grade-b-cell . live .
  8. 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) . AbbVie . PR Newswire . 19 May 2023 . 20 May 2023 . 19 May 2023 . https://web.archive.org/web/20230519225549/https://www.prnewswire.com/news-releases/epkinly-epcoritamab-bysp-approved-by-us-fda-as-the-first-and-only-bispecific-antibody-to-treat-adult-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-dlbcl-301829783.html . live .
  9. Web site: Drug Approval Package: Epkinly . U.S. Food and Drug Administration (FDA) . 26 May 2023 . 30 May 2023.
  10. Frampton JE . Epcoritamab: First Approval . Drugs . 83 . 14 . 1331–1340 . September 2023 . 37597091 . 10.1007/s40265-023-01930-4 . 261030074 .
  11. Web site: Tepkinly: Pending EC decision . European Medicines Agency (EMA) . 21 July 2023 . 1 October 2023 . 1 October 2023 . https://web.archive.org/web/20231001042652/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/tepkinly . dead .
  12. Web site: Tepkinly Product information . Union Register of medicinal products . 25 September 2023 . 1 October 2023.
  13. Web site: EU/3/22/2581: Orphan designation for the treatment of diffuse large B-cell lymphoma . European Medicines Agency (EMA) . 21 July 2023 . 1 October 2023.
  14. Web site: EU/3/22/2634: Orphan designation for the treatment of follicular lymphoma . European Medicines Agency (EMA) . 10 May 2023 . 1 October 2023.
  15. Web site: EU/3/22/2581 . Union Register of medicinal products . 25 September 2023 . 1 October 2023.
  16. ((World Health Organization)) . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83 . WHO Drug Information . 34 . 1 . 2020 . 10665/339768 . free . World Health Organization .
  17. ((World Health Organization)) . 2022 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88 . WHO Drug Information . 36 . 3 . 10665/363551 . free . World Health Organization .

This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Epcoritamab".

Except where otherwise indicated, Everything.Explained.Today is © Copyright 2009-2024, A B Cryer, All Rights Reserved. Cookie policy.