Difference between revisions of "Binimetinib (Mektovi)"

Revision as of 15:22, 31 May 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 [https://clinicaltrials.gov/ct2/show/NCT01909453 Clinical Trial Registry 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

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 ==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])''
+*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/[https://clinicaltrials.gov/ct2/show/NCT01909453 Clinical Trial Registry] COLUMBUS])''
 ==History of changes in EMA indication==
 *2018-09-20: Initial authorization