Contents

Futibatinib

Futibatinib

Clinical data
Trade names	Lytgobi
Other names	TAS-120
AHFS/Drugs.com	Micromedex Detailed Consumer Information
License data	US DailyMed: Futibatinib
Routes of administration	By mouth
Drug class	Antineoplastic
ATC code	L01EN04 (WHO)
Legal status
Legal status	US: ℞-only[1][2][3] EU: Rx-only[4][5]
Identifiers
IUPAC name 1-[(3S)-3-[4-amino-3-[2-(3,5-dimethoxyphenyl)ethynyl]pyrazolo[3,4-d]pyrimidin-1-yl]pyrrolidin-1-yl]prop-2-en-1-one
CAS Number	1448169-71-8
PubChem CID	71621331
IUPHAR/BPS	9786
DrugBank	DB15149
ChemSpider	58877816
UNII	4B93MGE4AL
KEGG	D11725
ChEMBL	ChEMBL3701238
PDB ligand	TZ0 (PDBe, RCSB PDB)
Chemical and physical data
Formula	C22H22N6O3
Molar mass	418.457 g·mol−1
3D model (JSmol)	Interactive image
SMILES COC1=CC(=CC(OC)=C1)C#CC1=NN([C@H]2CCN(C2)C(=O)C=C)C2=C1C(N)=NC=N2
InChI InChI=1S/C22H22N6O3/c1-4-19(29)27-8-7-15(12-27)28-22-20(21(23)24-13-25-22)18(26-28)6-5-14-9-16(30-2)11-17(10-14)31-3/h4,9-11,13,15H,1,7-8,12H2,2-3H3,(H2,23,24,25)/t15-/m0/s1 Key:KEIPNCCJPRMIAX-HNNXBMFYSA-N

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[edit]

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[edit]

Legal status[edit]

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[edit]

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

References[edit]

1. ^ ^{a b c d e f} "Lytgobi- futibatinib tablet". DailyMed. 2 February 2023. Archived from the original on 12 April 2023. Retrieved 13 April 2023.

^ ^{a b c} "FDA grants accelerated approval to futibatinib for cholangiocarcinoma". U.S. Food and Drug Administration. 30 September 2022. Archived from the original on 4 December 2022. Retrieved 4 December 2022. This article incorporates text from this source, which is in the public domain.

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