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Name
Encorafenib
Alternate Names
BRAFTOVI
LGX818
Abbreviations
None
Category
Chemotherapy
Subcategory
NSC Number
None
Primary Site
Colon/Rectum
Lung
Skin
Histology
Melanoma; NSCLC;
Remarks
On 2/20/2026 FDA granted traditional approval to encorafenib (Braftovi) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test.
December 20, 2024, the FDA granted accelerated approval to encorafenib (Braftovi) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.
October 11, 2023, the FDA approved encorafenib (Braftovi) with binimetinib for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
April 8, 2020 Food and Drug Administration approved encorafenib (BRAFTOVI) 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.
June 27, 2018: FDA approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
December 20, 2024, the FDA granted accelerated approval to encorafenib (Braftovi) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.
October 11, 2023, the FDA approved encorafenib (Braftovi) with binimetinib for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
April 8, 2020 Food and Drug Administration approved encorafenib (BRAFTOVI) 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.
June 27, 2018: FDA approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Coding
This drug should be coded
