Difference between revisions of "Encorafenib (Braftovi)"
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*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. | *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== | ==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. | *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== | ||
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[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
[[Category:Health Canada approved in 2021]] | [[Category:Health Canada approved in 2021]] | ||
| + | [[Category:PMDA approved in 2019]] | ||
Revision as of 20:43, 8 June 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 established
History of changes in FDA indication
- 2018-06-27: 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)
- 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)
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: LGX818
- Brand name: Braftovi