Difference between revisions of "Encorafenib (Braftovi)"
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==General information== | ==General information== | ||
| − | Class/mechanism (from [ | + | Class/mechanism (from [https://www.cancer.gov/drugdictionary?CdrID=712549 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 | + | ==Diseases for which it is established== |
| − | *[[ | + | *[[Colorectal cancer, BRAF-mutated|BRAF-mutated CRC]] |
*[[Melanoma,_BRAF-mutated|BRAF-mutated melanoma]] | *[[Melanoma,_BRAF-mutated|BRAF-mutated melanoma]] | ||
| − | + | *[[Non-small cell lung cancer, BRAF-mutated|BRAF-mutated NSCLC]] | |
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2018-06-27: Initial 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)'' |
| − | * | + | *2020-04-09: 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)'' |
| + | *2023-10-11: Approved with [[Binimetinib (Mektovi)]] 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== | ||
| + | *2018-09-19: Iniital authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2021-03-02: Initial notice of compliance for use in combination with binimetinib for the treatment of adult 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== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' LGX-818 |
*'''Brand name:''' Braftovi | *'''Brand name:''' Braftovi | ||
| Line 17: | Line 25: | ||
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
[[Category:Mutation-specific medications]] | [[Category:Mutation-specific medications]] | ||
| − | |||
[[Category:BRAF inhibitors]] | [[Category:BRAF inhibitors]] | ||
| − | [[Category: | + | [[Category:Colorectal cancer medications]] |
[[Category:Melanoma medications]] | [[Category:Melanoma medications]] | ||
| + | [[Category:Non-small cell lung cancer medications]] | ||
| + | [[Category:EMA approved in 2018]] | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:Health Canada approved in 2021]] | ||
| + | [[Category:PMDA approved in 2019]] | ||
Latest revision as of 20:21, 27 June 2024
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 established
History of changes in FDA indication
- 2018-06-27: Initial 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)
- 2020-04-09: 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)
- 2023-10-11: Approved with Binimetinib (Mektovi) 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
- 2018-09-19: Iniital authorization
History of changes in Health Canada indication
- 2021-03-02: Initial notice of compliance for use in combination with binimetinib for the treatment of adult 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 name: LGX-818
- Brand name: Braftovi