Chemistry:Futibatinib
 | |
| Clinical data | |
|---|---|
| Trade names | Lytgobi |
| Other names | TAS-120 |
| AHFS/Drugs.com | Micromedex Detailed Consumer Information |
| License data |
|
| Routes of administration | By mouth |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| |
| CAS Number | |
| PubChem CID | |
| IUPHAR/BPS | |
| DrugBank | |
| ChemSpider | |
| UNII | |
| KEGG | |
| ChEMBL | |
| PDB ligand | |
| Chemical and physical data | |
| Formula | C22H22N6O3 |
| Molar mass | 418.457 g·mol−1 |
| 3D model (JSmol) | |
| |
| |
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
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
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.[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
Futibatinib is the international nonproprietary name (INN).[13]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 "Lytgobi- futibatinib tablet". 2 February 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b1332a1-0581-4707-9bf6-1eccfa39bef4.
- ↑ 2.0 2.1 2.2 "FDA grants accelerated approval to futibatinib for cholangiocarcinoma". U.S. Food and Drug Administration. 30 September 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-futibatinib-cholangiocarcinoma.
This article incorporates text from this source, which is in the public domain.
- ↑ 3.0 3.1 3.2 3.3 "Drug Approval Package: Lytgobi". U.S. Food and Drug Administration (FDA). 8 November 2022. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214801Orig1s000TOC.cfm.
- ↑ 4.0 4.1 4.2 "Lytgobi". 6 July 2023. https://ec.europa.eu/health/documents/community-register/html/h1741.htm.
- ↑ "Lytgobi EPAR". 18 July 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/lytgobi.
- ↑ "Lytgobi (Futibatinib) FDA Approval History". https://www.drugs.com/history/lytgobi.html.
- ↑ "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". 26 June 2023. https://www.taiho.co.jp/en/release/2023/20230626.html.
- ↑ "Futibatinib: First Approval". Drugs 82 (18): 1737–1743. December 2022. 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.
- ↑ "Futibatinib, an Irreversible FGFR1-4 Inhibitor for the Treatment of FGFR-Aberrant Tumors". The Oncologist 28 (11): 928–943. November 2023. doi:10.1093/oncolo/oyad149. PMID 37390492.
- ↑ 12.0 12.1 "Lytgobi: Pending EC decision". 26 April 2023. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/lytgobi. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information 33 (1). 2019.
 |  |
