Futibatinib

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][4] It is taken by mouth.[1]

Futibatinib
Clinical data
Trade namesLytgobi
Other namesTAS-120
AHFS/Drugs.comMicromedex Detailed Consumer Information
License data
Routes of
administration		By mouth
Drug classAntineoplastic
ATC code
Legal status
Legal status
Identifiers
  • 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
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
PDB ligand
Chemical and physical data
FormulaC22H22N6O3
Molar mass418.457 g·mol−1
3D model (JSmol)
  • COC1=CC(=CC(OC)=C1)C#CC1=NN([C@H]2CCN(C2)C(=O)C=C)C2=C1C(N)=NC=N2
  • 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 was approved for medical use in the United States in September 2022.[1][3][5][2]

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]

Society and culture

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.[6] The applicant for this medicinal product is Taiho Pharma Netherlands B.V.[6]

Names

Futibatinib is the international nonproprietary name (INN).[7]

References
  1. "Lytgobi- futibatinib tablet". DailyMed. 2 February 2023. Retrieved 13 April 2023.
  2. "FDA grants accelerated approval to futibatinib for cholangiocarcinoma". U.S. Food and Drug Administration. 30 September 2022. Retrieved 4 December 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  3. "Drug Approval Package: Lytgobi". U.S. Food and Drug Administration (FDA). 8 November 2022. Retrieved 18 November 2022.
  4. "Lytgobi (Futibatinib) FDA Approval History". Archived from the original on 4 October 2022. Retrieved 4 October 2022.
  5. "FDA Approves Taiho's Lytgobi (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma" (Press release). Taiho Oncology. 30 September 2022. Archived from the original on 4 October 2022. Retrieved 4 October 2022 – via PR Newswire.
  6. "Lytgobi: Pending EC decision". European Medicines Agency. 26 April 2023. Retrieved 27 April 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information. 33 (1). hdl:10665/330896.


This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.