Английская Википедия:Futibatinib

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Futibatinib, sold under the brand name Lytgobi, is an anti-cancer medication used for the treatment of cholangiocarcinoma (bile duct cancer).[1][2] It is a kinase inhibitor.[1][3] It is taken by mouth.[1]

Futibatinib was approved for medical use in the United States in September 2022,[1][2][4][5] in Japan in June 2023[6][7] and in the European Union in July 2023.[8][9]

Medical uses

Futibatinib is indicated for the treatment of adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.[1][2][5][10]

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 Lytgobi, intended for the second-line treatment of locally advanced or metastatic cholangiocarcinoma characterized by fusion or rearrangements of fibroblast growth factor receptor (FGFR) 2.[11] The applicant for this medicinal product is Taiho Pharma Netherlands B.V.[11] Futibatinib was approved for medical use in the European Union in July 2023.[8]

Names

Futibatinib is the international nonproprietary name (INN).[12]

References

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  1. 1,0 1,1 1,2 1,3 1,4 Ошибка цитирования Неверный тег <ref>; для сносок Lytgobi FDA label не указан текст
  2. 2,0 2,1 2,2 Шаблон:Cite web
  3. Шаблон:Cite web
  4. Шаблон:Cite press release
  5. 5,0 5,1 Шаблон:Cite web Шаблон:PD-notice
  6. Шаблон:Cite web
  7. Шаблон:Cite journal
  8. 8,0 8,1 Ошибка цитирования Неверный тег <ref>; для сносок Lytgobi EU не указан текст
  9. Шаблон:Cite press release
  10. Шаблон:Cite journal
  11. 11,0 11,1 Шаблон:Cite web Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  12. Шаблон:Cite journal