Английская Википедия:Glofitamab
Шаблон:Short description Шаблон:Use American English Шаблон:Use dmy dates Шаблон:Infobox drug
Glofitamab, sold under the brand name Columvi, is a bispecific monoclonal antibody used for the treatment of diffuse large B-cell lymphoma.[1] It is a bispecific CD20-directed CD3 T-cell engager.[2]
It was approved for medical use in Canada in July 2023,[3][4] in the United States in June 2023,[5][6] and in the European Union in July 2023.[7][8]
Medical uses
Glofitamab is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma.[2][5]
Adverse effects
The US Food and Drug Administration (FDA) label includes a boxed warning for serious or fatal cytokine release syndrome.[5]
Society and culture
Legal status
On 26 April 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Columvi, intended for the treatment of diffuse large B‑cell lymphoma (DLBCL).[9] The applicant for this medicinal product is Roche Registration GmbH.[9] Glofitamab was approved for medical use in the European Union in July 2023.[7]
Names
Glofitamab is the international nonproprietary name.[10]
References
Further reading
External links
Шаблон:Monoclonals for tumors Шаблон:Targeted cancer therapeutic agents
- ↑ Шаблон:Cite web
- ↑ 2,0 2,1 Ошибка цитирования Неверный тег
<ref>; для сносокColumvi FDA labelне указан текст - ↑ Ошибка цитирования Неверный тег
<ref>; для сносокColumvi PI CAне указан текст - ↑ Шаблон:Cite press release
- ↑ 5,0 5,1 5,2 Шаблон:Cite press release Шаблон:PD-notice
- ↑ Шаблон:Cite press release
- ↑ 7,0 7,1 Ошибка цитирования Неверный тег
<ref>; для сносокColumvi EUне указан текст - ↑ Шаблон:Cite press release
- ↑ 9,0 9,1 Шаблон:Cite web Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ Шаблон:Cite journal
- Английская Википедия
- Drugs developed by Hoffmann-La Roche
- Immunomodulating drugs
- Monoclonal antibodies for tumors
- Orphan drugs
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