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== | ==Diseases for which it is established== | ||
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*[[Melanoma,_BRAF-mutated|BRAF-mutant melanoma]] | *[[Melanoma,_BRAF-mutated|BRAF-mutant melanoma]] | ||
*[[Non-small cell lung cancer, BRAF-mutated|BRAF-mutant NSCLC]] | *[[Non-small cell lung cancer, BRAF-mutated|BRAF-mutant NSCLC]] | ||
| − | *[[Melanoma,_NRAS-mutated| | + | *[[Melanoma,_NRAS-mutated|Not reportedAS-mutant melanoma]] |
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
Latest revision as of 10:57, 6 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