Futibatinib

Futibatinib
Names
Trade namesLytgobi
Other namesTAS-120
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
Clinical data
Drug classAntineoplastic
Main usesBile duct cancer[1]
Side effectsNail problems, muscle pain, constipation, diarrhea, tiredness, dry mouth, hair loss, kidney problems, liver problems, low platelets, low white blood cells, electrolyte problems, urinary tract infection[2]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Routes of
use		By mouth
Typical dose20 mg OD[2]
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status
Chemical and physical data
FormulaC22H22N6O3
Molar mass418.457 g·mol−1
3D model (JSmol)
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 a medication used to treat bile duct cancer (cholangiocarcinoma).[1] Specifically it is used for cases that cannot be removed by surgery, are fibroblast growth factor receptor 2 (FGFR2) gene fusion positive, and have failed other treatment.[1] It is taken by mouth.[1]

Common side effects include nail problems, muscle pain, constipation, diarrhea, tiredness, dry mouth, hair loss, kidney problems, liver problems, low platelets, low white blood cells, electrolyte problems, and urinary tract infection.[2] Other side effects may include eye problems (retinal detachment) and soft tissue mineralization.[2] Use in pregnancy may harm the baby.[2][5] It is a kinase inhibitor, specifically a FGFR1-4 inhibitor.[2][5]

Futibatinib was approved for medical use in the United States in 2022.[1][2] While an application for approved has been submitted in Europe it is not approved their as of 2022.[1] The potential cost in the United States is unclear as of October 2022.[6]

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.[2][4][3]

Dosage

It is generally taken at a dose of 20 mg once per day.[2]

Names

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

References

  1. 1 2 3 4 5 6 "Futibatinib". SPS - Specialist Pharmacy Service. 13 September 2021. Archived from the original on 20 August 2022. Retrieved 16 December 2022.
  2. 1 2 3 4 5 6 7 8 9 10 "Archive copy" (PDF). Archived (PDF) from the original on 2022-10-11. Retrieved 2022-12-04.{{cite web}}: CS1 maint: archived copy as title (link)
  3. 1 2 "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. Public Domain This article incorporates text from this source, which is in the public domain.
  4. 1 2 "Drug Approval Package: Lytgobi". U.S. Food and Drug Administration (FDA). 8 November 2022. Archived from the original on 19 November 2022. Retrieved 18 November 2022.
  5. 1 2 "Orphan Drugs Take Specialty Rx Spotlight in 2022". www.specialtypharmacycontinuum.com. Archived from the original on 12 January 2023. Retrieved 12 January 2023.
  6. ↑ Kansteiner, Fraiser (3 October 2022). "Otsuka's Taiho Oncology bags approval for bile duct cancer med Lytgobi, teeing up showdown with BridgeBio and Incyte". Fierce Pharma. Archived from the original on 21 December 2022. Retrieved 21 December 2022.
  7. ↑ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information. 33 (1). hdl:10665/330896.
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