Braftovi (encorafenib) [package insert]. FDA.
Regulatory approval published by the Food and Drug Administration.
Citation
Array BioPharma, Inc. Braftovi (encorafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210496s021lbl.pdf. Revised February 2026. Accessed March 2, 2026.
Regulatory approvals
Approved indications from this document for cancer drugs containing at least one biomarker.
| Indication |
Statements |
| BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. |
2 |
| BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. |
1 |
| BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. |
1 |
| BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. |
2 |
Therapeutic response
Precision oncology relationships for therapeutic response derived from this document.
| Organization(s) |
Biomarker(s) |
Cancer type |
Therapy(ies) |
|
|
FDA (1)
|
BRAF p.V600E
|
Melanoma |
Binimetinib,
Encorafenib
|
|
|
FDA (1)
|
BRAF p.V600K
|
Melanoma |
Binimetinib,
Encorafenib
|
|
|
FDA (1)
|
BRAF p.V600E
|
Non-Small Cell Lung Cancer |
Binimetinib,
Encorafenib
|
|
|
FDA (1)
|
BRAF p.V600E
|
Colorectal Adenocarcinoma |
Cetuximab,
Encorafenib
|
|
|
FDA (1)
|
BRAF p.V600E
|
Colorectal Adenocarcinoma |
Cetuximab,
Encorafenib,
Fluorouracil,
Oxaliplatin
|
|
|
FDA (1)
|
BRAF p.V600E
|
Colorectal Adenocarcinoma |
Cetuximab,
Encorafenib,
Fluorouracil,
Irinotecan
|
|