Difference between revisions of "Pemigatinib (Pemazyre)"
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*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. | *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== | ==History of changes in PMDA indication== | ||
| − | *2021-03-21: Newly indicated for the treatment of unresectable FGFR2 fusion gene-positive [[:Category:Biliary tract cancer]] that has progressed after cancer chemotherapy. | + | *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:''' INCB054828 | *'''Code name:''' INCB054828 | ||
Revision as of 01:14, 7 June 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: INCB054828
- Brand name: Pemazyre