Difference between revisions of "Encorafenib (Braftovi)"
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*6/27/2018: Initial FDA approval in combination with [[Binimetinib (Mektovi)]] 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)'' | *6/27/2018: Initial FDA approval in combination with [[Binimetinib (Mektovi)]] 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)'' | ||
*4/9/2020: Approved in combination with cetuximab for the treatment of adult patients with metastatic [[colorectal cancer|colorectal cancer (CRC)]] with a [[Biomarkers#BRAF|BRAF]] [[Biomarkers#V600E|V600E mutation]], detected by an FDA-approved test, after prior therapy. ''(Based on BEACON CRC)'' | *4/9/2020: Approved in combination with cetuximab for the treatment of adult patients with metastatic [[colorectal cancer|colorectal cancer (CRC)]] with a [[Biomarkers#BRAF|BRAF]] [[Biomarkers#V600E|V600E mutation]], detected by an FDA-approved test, after prior therapy. ''(Based on BEACON CRC)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *9/19/2018: Iniital authorization | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' LGX818 | *'''Code name:''' LGX818 | ||
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[[Category:Melanoma medications]] | [[Category:Melanoma medications]] | ||
| + | [[Category:EMA approved in 2018]] | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
Revision as of 14:44, 1 January 2023
General information
Class/mechanism (from NCI Drug Dictionary): An orally available Raf kinase inhibitor with potential antineoplastic activity. LGX818 specifically inhibits Raf kinase, a serine/threonine enzyme in the RAF/mitogen-activated protein kinase kinase (MEK)/extracellular signal-related kinase (ERK) signaling pathway.
Diseases for which it is used
History of changes in FDA indication
- 6/27/2018: Initial FDA approval in combination with Binimetinib (Mektovi) for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. (Based on COLUMBUS)
- 4/9/2020: Approved in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy. (Based on BEACON CRC)
History of changes in EMA indication
- 9/19/2018: Iniital authorization
Also known as
- Code name: LGX818
- Brand name: Braftovi