Futibatinib information

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; EU: Rx-only;
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]

^ ^a ^b ^c ^d ^e "Lytgobi- futibatinib tablet". DailyMed. 2 February 2023. Archived from the original on 12 April 2023. Retrieved 13 April 2023.
^ ^a ^b Cite error: The named reference FDA futibatinib was invoked but never defined (see the help page).
^ ^a ^b ^c "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.
^ ^a ^b "Lytgobi". Union Register of medicinal products. 6 July 2023. Archived from the original on 14 July 2023. Retrieved 14 July 2023.
^ "Lytgobi EPAR". European Medicines Agency. 18 July 2023. Retrieved 25 August 2023.
^ "Lytgobi (Futibatinib) FDA Approval History". Archived from the original on 4 October 2022. Retrieved 4 October 2022.
^ "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.
^ "Taiho Pharmaceutical Obtains Approval in Japan to Manufacture and Market FGFR Inhibitor LYTGOBI® Tablets 4mg for Unresectable Biliary Tract Cancer Harboring FGFR2 Gene Fusions That Has Progressed After Chemotherapy". Taiho Pharmaceutical Co., Ltd. 26 June 2023. Retrieved 17 August 2023.
^ Syed YY (December 2022). "Futibatinib: First Approval". Drugs. 82 (18): 1737–1743. doi:10.1007/s40265-022-01806-z. PMID 36441501.
^ "European Commission Grants Conditional Marketing Authorization for Taiho's Lytgobi Tablets for the Treatment of Adults With Cholangiocarcinoma" (Press release). Taiho Oncology Europe. 4 July 2023. Retrieved 14 July 2023 – via PR Newswire.

[Lytgobi_FDA_label-1] "Lytgobi- futibatinib tablet". DailyMed. 2 February 2023. Archived from the original on 12 April 2023. Retrieved 13 April 2023.

[FDA_futibatinib-2] Cite error: The named reference FDA futibatinib was invoked but never defined (see the help page).

[Lytgobi_Drug_Approval_Package-3] "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.

[Lytgobi_EU-4] "Lytgobi". Union Register of medicinal products. 6 July 2023. Archived from the original on 14 July 2023. Retrieved 14 July 2023.

[5] "Lytgobi EPAR". European Medicines Agency. 18 July 2023. Retrieved 25 August 2023.

[6] "Lytgobi (Futibatinib) FDA Approval History". Archived from the original on 4 October 2022. Retrieved 4 October 2022.

[7] "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.

[8] "Taiho Pharmaceutical Obtains Approval in Japan to Manufacture and Market FGFR Inhibitor LYTGOBI® Tablets 4mg for Unresectable Biliary Tract Cancer Harboring FGFR2 Gene Fusions That Has Progressed After Chemotherapy". Taiho Pharmaceutical Co., Ltd. 26 June 2023. Retrieved 17 August 2023.

[pmid36441501-9] Syed YY (December 2022). "Futibatinib: First Approval". Drugs. 82 (18): 1737–1743. doi:10.1007/s40265-022-01806-z. PMID 36441501.

[10] "European Commission Grants Conditional Marketing Authorization for Taiho's Lytgobi Tablets for the Treatment of Adults With Cholangiocarcinoma" (Press release). Taiho Oncology Europe. 4 July 2023. Retrieved 14 July 2023 – via PR Newswire.

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