Difference between revisions of "Binimetinib (Mektovi)"
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| − | =Mechanism of action= | + | ==Mechanism of action== |
| − | From the [ | + | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=653635 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 established== |
| + | *[[Colorectal cancer, BRAF-mutated|BRAF-mutant colorectal cancer]] | ||
| + | *[[Melanoma,_BRAF-mutated|BRAF-mutant melanoma]] | ||
| + | *[[Non-small cell lung cancer, BRAF-mutated|BRAF-mutant NSCLC]] | ||
| + | *[[Melanoma,_NRAS-mutated|NRAS-mutant melanoma]] | ||
| − | ==[[ | + | ==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 COLUMBUS)'' | |
| − | + | *2023-10-11: Approved with [[Encorafenib (Braftovi)]] for adult patients with metastatic [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] with a BRAF V600E mutation, as detected by an FDA-approved test. ''(Based on PHAROS)'' | |
| − | = | + | ==History of changes in EMA indication== |
| − | + | *2018-09-20: Initial authorization as Mektovi. Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic [[melanoma]] with a BRAF V600 mutation. ''(Based on COLUMBUS and LOGIC-2)'' | |
| + | *2020-04-30: Extension of indication to include encorafenib in combination with cetuximab, for the treatment of adult patients with metastatic [[colorectal cancer|colorectal cancer (CRC)]] with a BRAF V600E mutation, who have received prior systemic therapy. | ||
| − | [[ | + | ==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, MEK-162 | ||
| + | *'''Brand names:''' Mektovi | ||
| − | [[Category: | + | [[Category:Drugs]] |
| − | [[Category:Oral | + | [[Category:Oral medications]] |
| + | [[Category:Mutation-specific medications]] | ||
| − | [[Category: | + | [[Category:MAP2K1 inhibitors]] |
| − | [[Category: | + | [[Category:MAP2K2 inhibitors]] |
| + | [[Category:Colorectal cancer medications]] | ||
[[Category:Melanoma medications]] | [[Category:Melanoma medications]] | ||
| + | [[Category:Non-small cell lung cancer medications]] | ||
| − | [[Category: | + | [[Category:EMA approved in 2018]] |
| + | [[Category:FDA approved in 2018]] | ||
| + | [[Category:Health Canada approved in 2021]] | ||
| + | [[Category:PMDA approved in 2019]] | ||
Latest revision as of 01:03, 23 July 2024
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 established
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)
- 2023-10-11: Approved with Encorafenib (Braftovi) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. (Based on PHAROS)
History of changes in EMA indication
- 2018-09-20: Initial authorization as Mektovi. Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. (Based on COLUMBUS and LOGIC-2)
- 2020-04-30: Extension of indication to include encorafenib in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy.
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, MEK-162
- Brand names: Mektovi