Futibatinib

Futibatinib, sold under the brand name Lytgobi, is an anti-cancer medication used for the treatment of cholangiocarcinoma (bile duct cancer).

[1] Futibatinib was approved for medical use in the United States in September 2022,[1][3][7][2] in Japan in June 2023[8][9] and in the European Union in July 2023.

[4][10] 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][3][2][11] 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.

[12] The applicant for this medicinal product is Taiho Pharma Netherlands B.V.[12] Futibatinib was approved for medical use in the European Union in July 2023.