Futibatinib Explained

Tradename:Lytgobi
Dailymedid:Futibatinib
Routes Of Administration:By mouth
Class:Antineoplastic
Atc Prefix:L01
Atc Suffix:EN04
Legal Us:Rx-only
Legal Us Comment:[1]
Legal Eu:Rx-only
Legal Eu Comment:[2] [3]
Cas Number:1448169-71-8
Pubchem:71621331
Iuphar Ligand:9786
Drugbank:DB15149
Chemspiderid:58877816
Unii:4B93MGE4AL
Kegg:D11725
Chembl:3701238
Pdb Ligand:TZ0
Synonyms:TAS-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
C:22
H:22
N:6
O:3
Smiles:COC1=CC(=CC(OC)=C1)C#CC1=NN([C@H]2CCN(C2)C(=O)C=C)C2=C1C(N)=NC=N2
Stdinchi: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
Stdinchikey:KEIPNCCJPRMIAX-HNNXBMFYSA-N

Futibatinib, sold under the brand name Lytgobi, is an anti-cancer medication used for the treatment of cholangiocarcinoma (bile duct cancer). It is a kinase inhibitor.[4] It is taken by mouth.

Futibatinib was approved for medical use in the United States in September 2022,[5] [6] in Japan in June 2023[7] [8] and in the European Union in July 2023.[9]

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.[10] [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. 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.

Names

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

Notes and References

  1. Web site: Lytgobi- futibatinib tablet . DailyMed . 2 February 2023 . 13 April 2023 . 12 April 2023 . https://web.archive.org/web/20230412133502/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b1332a1-0581-4707-9bf6-1eccfa39bef4 . live .
  2. Web site: Lytgobi . Union Register of medicinal products . 6 July 2023 . 14 July 2023 . 14 July 2023 . https://web.archive.org/web/20230714201937/https://ec.europa.eu/health/documents/community-register/html/h1741.htm . live .
  3. Web site: Lytgobi EPAR . European Medicines Agency . 18 July 2023 . 25 August 2023.
  4. Web site: Lytgobi (Futibatinib) FDA Approval History . 4 October 2022 . 4 October 2022 . https://web.archive.org/web/20221004032909/https://www.drugs.com/history/lytgobi.html . live .
  5. Web site: Drug Approval Package: Lytgobi . U.S. Food and Drug Administration (FDA) . 8 November 2022 . 18 November 2022 . 19 November 2022 . https://web.archive.org/web/20221119000146/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214801Orig1s000TOC.cfm . live .
  6. FDA Approves Taiho's Lytgobi (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma . Taiho Oncology . PR Newswire . 30 September 2022 . 4 October 2022 . 4 October 2022 . https://web.archive.org/web/20221004020822/https://www.prnewswire.com/news-releases/fda-approves-taihos-lytgobi-futibatinib-tablets-for-previously-treated-unresectable-locally-advanced-or-metastatic-intrahepatic-cholangiocarcinoma-301638254.html . live .
  7. Web site: 26 June 2023 . 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 . 17 August 2023 . Taiho Pharmaceutical Co., Ltd..
  8. Syed YY . Futibatinib: First Approval . Drugs . 82 . 18 . 1737–1743 . December 2022 . 36441501 . 10.1007/s40265-022-01806-z .
  9. European Commission Grants Conditional Marketing Authorization for Taiho's Lytgobi Tablets for the Treatment of Adults With Cholangiocarcinoma . Taiho Oncology Europe . PR Newswire . 4 July 2023 . 14 July 2023.
  10. Web site: FDA grants accelerated approval to futibatinib for cholangiocarcinoma . U.S. Food and Drug Administration . 30 September 2022 . 4 December 2022 . 4 December 2022 . https://web.archive.org/web/20221204073236/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-futibatinib-cholangiocarcinoma . live .
  11. Javle M, King G, Spencer K, Borad MJ . Futibatinib, an Irreversible FGFR1-4 Inhibitor for the Treatment of FGFR-Aberrant Tumors . The Oncologist . 28 . 11 . 928–943 . November 2023 . 37390492 . 10628593 . 10.1093/oncolo/oyad149 .
  12. Web site: Lytgobi: Pending EC decision . European Medicines Agency . 26 April 2023 . 27 April 2023 . 27 April 2023 . https://web.archive.org/web/20230427002215/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/lytgobi . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  13. ((World Health Organization)) . 2019 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81 . WHO Drug Information . 33 . 1 . 10665/330896 . free . World Health Organization .

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