Difference between revisions of "Infigratinib (Truseltiq)"
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m (Jwarner moved page Infigratinib (BGJ398) to Infigratinib (Truseltiq): FDA approval with new brand name) |
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2021-05-28: Accelerated approval for adults with previously treated, unresectable locally advanced or metastatic [[cholangiocarcinoma]] with a [[Biomarkers#FGFR2|fibroblast growth factor receptor 2 (FGFR2)]] [[Biomarkers#fusion|fusion]] or other [[Biomarkers#Rearrangement|rearrangement]] as detected by an FDA-approved test. ''(Based on CBGJ398X2204)'' |
| − | + | ==History of changes in Health Canada indication== | |
| + | *2021-09-27: Initial notice of compliance with conditions for the treatment of adults with previously treated, unresectable locally advanced or metastatic [[cholangiocarcinoma]] with a fibroblast growth factor receptor 2 fusion or other rearrangement. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' BGJ398 | *'''Code name:''' BGJ398 | ||
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[[Category:FDA approved in 2021]] | [[Category:FDA approved in 2021]] | ||
| + | [[Category:Health Canada approved in 2021]] | ||
Revision as of 11:57, 31 March 2023
Mechanism of action
From the NCI Drug Dictionary: An orally bioavailable pan inhibitor of human fibroblast growth factor receptors (FGFRs) with potential antiangiogenic and antineoplastic activities. Infigratinib selectively binds to and inhibits the activities of FGFRs, which may result in the inhibition of tumor angiogenesis and tumor cell proliferation, and the induction of tumor cell death.
Diseases for which it is used
History of changes in FDA indication
- 2021-05-28: Accelerated approval for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. (Based on CBGJ398X2204)
History of changes in Health Canada indication
- 2021-09-27: Initial notice of compliance with conditions for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement.
Also known as
- Code name: BGJ398
- Brand name: Truseltiq