Difference between revisions of "Binimetinib (Mektovi)"
Jump to navigation
Jump to search
Warner-admin (talk | contribs) m (Text replacement - ": new" to ": New") |
Warner-admin (talk | contribs) m (Text replacement - "clinicaltrials.gov/ct2/show" to "clinicaltrials.gov/study") |
||
| Line 8: | Line 8: | ||
==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/ | + | *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/study/NCT01909453 Clinical Trial Registry] COLUMBUS])'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2018-09-20: Initial authorization | *2018-09-20: Initial authorization | ||
Revision as of 01:43, 25 June 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 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.
History of changes in PMDA indication
- 2019-01-08: New approval for the treatment of unresectable melanoma with BRAF gene mutation.
- 2020-11-27: New indication and a new dosage for the treatment of unresectable, advanced or recurrent BRAF mutation-positive colorectal cancer that has progressed after cancer chemotherapy.
Also known as
- Code names: ARRY-162, ARRY-438162, MEK162
- Brand names: Mektovi