Epcoritamab

Epcoritamab
Monoclonal antibody
TypeBi-specific T-cell engager
SourceHumanized
TargetCD3E, CD20
Names
Trade namesEpkinly
Other namesEpcoritamab-bysp, GEN3013
Clinical data
Drug classAntineoplastic
Main usesDiffuse large B-cell lymphoma (DLBCL)[1]
Side effectsCytokine release syndrome, tiredness, musculoskeletal pain, injection site reactions, fever, abdominal pain, nausea, diarrhea[1]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Routes of
use		Subcutaneous
Legal
License data
Legal status
Chemical and physical data
FormulaC6471H9999N1735O2007S44
Molar mass145624.95 g·mol−1

Epcoritamab, sold under the brand name Epkinly, is a medication used to treat diffuse large B-cell lymphoma (DLBCL).[1] It is used when other treatments are not effective.[1] It is given by injection under the skin.[1]

Common side effects include cytokine release syndrome, tiredness, musculoskeletal pain, injection site reactions, fever, abdominal pain, nausea, and diarrhea.[1] Other side effects may include infection and low blood cells.[1] Use in pregnancy may harm the baby.[1] It is a monoclonal antibody that is a bispecific CD20-directed CD3 T-cell engager.[1]

Epcoritamab was approved for medical use in the United States in 2023.[1] In the United States it costs about 18,000 USD per dose as of 2023.[2]

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.[1][3][4]


History

Epcoritamab, was evaluated in EPCORE NHL-1 (NCT03625037), an open-label, multi-cohort, multicenter, single-arm trial in participants with relapsed or refractory B-cell lymphoma.[3] The efficacy population consisted of 148 participants 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, including at least one anti-CD20 monoclonal antibody-containing therapy.[3]

Society and culture

Names

Epcoritamab is the international nonproprietary name.[5][6]

References

  1. 1 2 3 4 5 6 7 8 9 10 11 12 "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.
  2. ↑ "Epkinly Prices, Coupons, Copay & Patient Assistance". Drugs.com. Archived from the original on 15 August 2023. Retrieved 15 August 2023.
  3. 1 2 3 "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.
  4. ↑ "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.
  5. ↑ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.
  6. ↑ 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

Identifiers:
  • 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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