Encorafenib (Braftovi)

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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

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