Difference between revisions of "Binimetinib (Mektovi)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2018-06-27: Initial FDA approval in combination with [[Encorafenib (Braftovi)]] for patients with unresectable or metastatic [[melanoma]] with a [[Biomarkers#BRAF|BRAF]] [[Biomarkers#V600E|V600E]] or [[Biomarkers#V600K|V600K mutation]], as detected by an FDA-approved test. ''(Based on [https://clinicaltrials.gov/ct2/show/NCT01909453 COLUMBUS])'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | * | + | *2018-09-20: Initial authorization |
| + | ==History of changes in Health Canada indication== | ||
| + | *2021-03-02: Initial notice of compliance in combination with encorafenib for the treatment of patients with unresectable or metastatic [[melanoma]] with a BRAF V600 mutation, as detected by a validated test. | ||
| + | |||
==Also known as== | ==Also known as== | ||
*'''Code names:''' ARRY-162, ARRY-438162, MEK162 | *'''Code names:''' ARRY-162, ARRY-438162, MEK162 | ||
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[[Category:EMA approved in 2018]] | [[Category:EMA approved in 2018]] | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:Health Canada approved in 2021]] | ||
Revision as of 00:20, 3 April 2023
Mechanism of action
From the NCI Drug Dictionary: An orally available inhibitor of mitogen-activated protein kinase kinase 1 and 2 (MEK1/2) with potential antineoplastic activity. Binimetinib, noncompetitive with ATP, binds to and inhibits the activity of MEK1/2.
Diseases for which it is used
History of changes in FDA indication
- 2018-06-27: Initial FDA approval in combination with Encorafenib (Braftovi) for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. (Based on COLUMBUS)
History of changes in EMA indication
- 2018-09-20: Initial authorization
History of changes in Health Canada indication
- 2021-03-02: Initial notice of compliance in combination with encorafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.
Also known as
- Code names: ARRY-162, ARRY-438162, MEK162
- Brand names: Mektovi