Difference between revisions of "Pemigatinib (Pemazyre)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*4/17/2020: Granted accelerated approval for the treatment of 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]]. ''(Based on FIGHT-202)'' | *4/17/2020: Granted accelerated approval for the treatment of 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]]. ''(Based on FIGHT-202)'' | ||
| − | *8/26/2022: Approved for adults with relapsed or refractory [[:Category:Malignant hematologic neoplasm|myeloid/lymphoid neoplasms (MLNs)]] with [[Biomarkers#FGFR1|fibroblast growth factor receptor 1 (FGFR1)]] [[Biomarkers#fusion|rearrangement]]. | + | *8/26/2022: Approved for adults with relapsed or refractory [[:Category:Malignant hematologic neoplasm|myeloid/lymphoid neoplasms (MLNs)]] with [[Biomarkers#FGFR1|fibroblast growth factor receptor 1 (FGFR1)]] [[Biomarkers#fusion|rearrangement]]. ''(Based on FIGHT-203)'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
Revision as of 12:05, 30 August 2022
General information
Class/mechanism from the NCI Drug Dictionary: An orally bioavailable inhibitor of the fibroblast growth factor receptor (FGFR) types 1, 2, and 3 (FGFR1/2/3), with potential antineoplastic activity. Pemigatinib binds to and inhibits FGFR1/2/3, which may result in the inhibition of FGFR1/2/3-related signal transduction pathways. This inhibits proliferation in FGFR1/2/3-overexpressing tumor cells.
Diseases for which it is used
History of changes in FDA indication
- 4/17/2020: Granted accelerated approval for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. (Based on FIGHT-202)
- 8/26/2022: Approved for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement. (Based on FIGHT-203)
History of changes in EMA indication
- 3/26/2021: Initial marketing authorization as Pemazyre.
Also known as
- Code name: INCB054828
- Brand name: Pemazyre