Chemistry:Epcoritamab

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Epcoritamab, sold under the brand name Epkinly, is a Bi-specific T-cell engager (BiTE) used for the treatment of diffuse large B-cell lymphoma.[1][2] Epcoritamab is a bispecific CD20-directed CD3 T-cell engager.[1][2] Epcoritamab was co-developed by AbbVie and Genmab.[3]

Epcoritamab was approved for medical use in the United States in May 2023,[2][4][3][5][6] in the European Union in September 2023,[7] and in Canada in December 2023.[8]

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][2][4]

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.[9][10]

Side effects

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.[9] Warnings and precautions include serious infections and cytopenias.[9]

The most common adverse reactions include cytokine release syndrome, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea.[2]

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.[2]

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.[9] The primary efficacy and safety were based on 127 participants who received a two step-up dosing regimen.[9] A separate dose optimization cohort of 86 participants evaluated the recommended 3-step up dosage schedule for cytokine release syndrome mitigation.[9]

The US Food and Drug Administration (FDA) granted the application for epcoritamab for follicular lymphoma priority review and breakthrough therapy designations.[9]

Society and culture

In July 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency 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]

References

  1. ↑ 1.0 1.1 1.2 Cite error: Invalid <ref> tag; no text was provided for refs named Epkinly FDA label
  2. ↑ 2.0 2.1 2.2 2.3 2.4 2.5 "FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma". 19 May 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b-cell.  Public Domain This article incorporates text from this source, which is in the public domain.
  3. ↑ 3.0 3.1 "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.
  4. ↑ 4.0 4.1 "FDA approves treatment for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma". 19 May 2023. 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.  Public Domain This article incorporates text from this source, which is in the public domain.
  5. ↑ "Drug Approval Package: Epkinly". 26 May 2023. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761324Orig1s000TOC.cfm. 
  6. ↑ "Epcoritamab: First Approval". Drugs 83 (14): 1331–1340. September 2023. doi:10.1007/s40265-023-01930-4. PMID 37597091. 
  7. ↑ Cite error: Invalid <ref> tag; no text was provided for refs named Tepkinly EPAR
  8. ↑ Cite error: Invalid <ref> tag; no text was provided for refs named Epkinly PI CA
  9. ↑ 9.0 9.1 9.2 9.3 9.4 9.5 9.6 "FDA grants accelerated approval to epcoritamab-bysp". 26 June 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-follicular-lymphoma. 
  10. ↑ "Cancer Accelerated Approvals". 1 October 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals. 
  11. ↑ "Tepkinly: Pending EC decision". 21 July 2023. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/tepkinly. 
  12. ↑ "Tepkinly Product information". 25 September 2023. https://ec.europa.eu/health/documents/community-register/html/h1759.htm. 
  13. ↑ "EU/3/22/2581: Orphan designation for the treatment of diffuse large B-cell lymphoma". 21 July 2023. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2581. 
  14. ↑ "EU/3/22/2634: Orphan designation for the treatment of follicular lymphoma". 10 May 2023. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2634. 
  15. ↑ "EU/3/22/2581". 25 September 2023. https://ec.europa.eu/health/documents/community-register/html/o2581.htm. 
  16. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information 34 (1). 2020. 
  17. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information 36 (3). 2022. 

Further reading

  • 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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