Difference between revisions of "Pemigatinib (Pemazyre)"
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==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Cholangiocarcinoma]] | *[[Cholangiocarcinoma]] | ||
| + | *[[FGFR1|FGFR1+ myeloid/lymphoid neoplasms (site-agnostic)]] | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2020-04-17: 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)'' |
| + | *2022-08-26: 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== | ||
| + | *2021-03-26: Initial conditional authorization as Pemazyre. | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2021-09-17: 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 (FGFR2) fusion or other rearrangement. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2021-03-21: Newly 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== | ||
| − | *'''Code name:''' | + | *'''Code name:''' INCB-054828 |
*'''Brand name:''' Pemazyre | *'''Brand name:''' Pemazyre | ||
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[[Category:Cholangiocarcinoma medications]] | [[Category:Cholangiocarcinoma medications]] | ||
| + | |||
| + | [[Category:EMA approved in 2021]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
| + | [[Category:Health Canada approved in 2021]] | ||
| + | [[Category:PMDA approved in 2021]] | ||
Latest revision as of 13:00, 8 September 2023
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
- 2020-04-17: 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)
- 2022-08-26: 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
- 2021-03-26: Initial conditional authorization as Pemazyre.
History of changes in Health Canada indication
- 2021-09-17: 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 (FGFR2) fusion or other rearrangement.
History of changes in PMDA indication
- 2021-03-21: Newly indicated for the treatment of unresectable FGFR2 fusion gene-positive biliary tract cancer that has progressed after cancer chemotherapy.
Also known as
- Code name: INCB-054828
- Brand name: Pemazyre