Английская Википедия:Epcoritamab

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Шаблон:Short description Шаблон:Use American English Шаблон:Use dmy dates Шаблон:Cs1 config Шаблон:Infobox drug

Epcoritamab, sold under the brand name Epkinly, is a monoclonal antibody anticancer medication 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,[1][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]

Side effects

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]

The efficacy outcome measure was overall response rate (ORR), which was 61%. Of those patients, 38% of patients achieved complete response.[2]

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).[9] It was approved for medical use in the European Union in September 2023.[10] The EMA granted orphan drug designation to epcoritamab in both February and June 2022.[11][12][13]

Names

Epcoritamab is the international nonproprietary name.[14][15]

References

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Further reading

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External links

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  1. 1,0 1,1 1,2 1,3 Ошибка цитирования Неверный тег <ref>; для сносок Epkinly FDA label не указан текст
  2. 2,0 2,1 2,2 2,3 2,4 2,5 2,6 Шаблон:Cite web Шаблон:PD-notice
  3. 3,0 3,1 Шаблон:Cite press release
  4. 4,0 4,1 Шаблон:Cite web Шаблон:PD-notice
  5. Шаблон:Cite web
  6. Шаблон:Cite journal
  7. Ошибка цитирования Неверный тег <ref>; для сносок Tepkinly EPAR не указан текст
  8. Ошибка цитирования Неверный тег <ref>; для сносок Epkinly PI CA не указан текст
  9. Шаблон:Cite web
  10. Шаблон:Cite web
  11. Шаблон:Cite web
  12. Шаблон:Cite web
  13. Шаблон:Cite web
  14. Шаблон:Cite journal
  15. Шаблон:Cite journal