Futibatinib

Routes of
administrationBy mouthDrug classAntineoplasticATC codeLegal statusLegal status IdentifiersCAS NumberPubChem CIDIUPHAR/BPSDrugBankChemSpiderUNIIKEGGChEMBLPDB ligandChemical and physical dataFormulaC₂₂H₂₂N₆O₃Molar mass418.457 g·mol⁻¹3D model (JSmol)

Futibatinib, sold under the brand name Lytgobi, is an anti-cancer medication used for the treatment of cholangiocarcinoma (bile duct cancer).^[1][3] It is a kinase inhibitor.^[1][6] It is taken by mouth.^[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]

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][3][2][11]}

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.^[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.^[4]

Names

Futibatinib is the international nonproprietary name (INN).^[13]

References