Difference between revisions of "Futibatinib (Lytgobi)"
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(Created page with "==General information== Class/mechanism from the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/futibatinib NCI Drug Dictionary]: An orally bioavailable inh...") |
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2022-09-30: Granted accelerated approval for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic [[cholangiocarcinoma]] harboring [[Biomarkers#FGFR2|fibroblast growth factor receptor 2 (FGFR2) gene]] [[Biomarkers#fusion|fusions]] or other [[Biomarkers#Rearrangement|rearrangements]]. ''(Based on FOENIX-CCA2)'' |
| + | ==History of changes in EMA indication== | ||
| + | *2023-07-04: Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic [[cholangiocarcinoma]] with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2023-06-26: A drug with a new active ingredient indicated for the treatment of unresectable FGFR2 fusion gene positive [[:Category:Biliary tract cancers|biliary tract cancer]] that has progressed after cancer chemotherapy. | ||
==Also known as== | ==Also known as== | ||
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[[Category:Cholangiocarcinoma medications]] | [[Category:Cholangiocarcinoma medications]] | ||
| + | [[Category:EMA approved in 2023]] | ||
[[Category:FDA approved in 2022]] | [[Category:FDA approved in 2022]] | ||
| + | [[Category:PMDA approved in 2023]] | ||
Latest revision as of 03:47, 1 June 2024
General information
Class/mechanism from the NCI Drug Dictionary: An orally bioavailable inhibitor of the fibroblast growth factor receptor (FGFR) with potential antineoplastic activity. Futibatinib selectively and irreversibly binds to and inhibits FGFR, which may result in the inhibition of both the FGFR-mediated signal transduction pathway and tumor cell proliferation, and increased cell death in FGFR-overexpressing tumor cells.
Diseases for which it is used
History of changes in FDA indication
- 2022-09-30: Granted accelerated approval for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. (Based on FOENIX-CCA2)
History of changes in EMA indication
- 2023-07-04: Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
History of changes in PMDA indication
- 2023-06-26: A drug with a new active ingredient indicated for the treatment of unresectable FGFR2 fusion gene positive biliary tract cancer that has progressed after cancer chemotherapy.
Also known as
- Code name: TAS-120
- Brand name: Lytgobi