BRAF V600E (and V600K)

aka BRAF V600E, V600E, BRAF V600, BRAF V600K, BRAF-mutant, BRAF class I mutation, BRAF V600E-mutant

V600E is the BRAF change that drives half of melanomas and many thyroid, bowel, lung and brain tumours. BRAF plus MEK inhibitors are approved for it in melanoma, lung, thyroid and, tumour-agnostically, any solid tumour; in bowel cancer it is treated with encorafenib and cetuximab.

The c.1799T>A (V600E) substitution, and the rarer V600K, are class I BRAF mutations that signal as monomers and respond to BRAF inhibitors. Dabrafenib and vemurafenib are labelled for BRAF V600E melanoma; dabrafenib with trametinib for V600E or V600K melanoma, V600E NSCLC, anaplastic thyroid cancer, paediatric low-grade glioma and V600E solid tumours (tumour-agnostic, 2022); encorafenib with binimetinib for V600E or V600K melanoma and V600E NSCLC, and with cetuximab for V600E colorectal cancer. Companion diagnostics on the FDA list include the cobas 4800 BRAF V600, THxID BRAF, therascreen BRAF V600E, FoundationOne CDx and Liquid CDx, Oncomine Dx Target Test, Guardant360 CDx and Caris MI Cancer Seek. Labels warn the drugs are not for BRAF wild-type tumours.

Part ofBRAF· BRAFOther readoutsBRAF class II and class III mutations BRAF fusion or rearrangement All readouts

BRAF: what it is and how drugs act on it · animated schematic, not to scale

Target · the protein and the cell it sits on
Drug · antibody, small molecule, cell or radioligand
Effect · signal, damage or kill

In plain words · BRAF is a signalling kinase mutated in half of melanomas; blocking it with two drugs at once became a template for targeted therapy.

Sequencing 6 approval thresholds

What it means for a patient

A BRAF V600E result opens targeted tablets: a BRAF inhibitor with a MEK inhibitor in melanoma, lung and thyroid cancer and many rarer tumours, and encorafenib with the antibody cetuximab in bowel cancer. In melanoma your team will weigh these against immunotherapy, which also works. A V600K result qualifies for the melanoma combinations; other BRAF changes (class II and III) do not.

Written only from the label or guideline text cited on this page. Not medical advice; your own report and the reading your team gives it come first.

Scoring rule

The BRAF c.1799T>A (p.V600E) substitution, or c.1798_1799GT>AA (p.V600K) where the label names it, detected by PCR or sequencing in tumour tissue or plasma.

“V600E or V600K”
FDA: List of FDA-Authorized Companion Diagnostic Devices

Thresholds used in approvals

Threshold	Drug	Cancer	Regulator	Source
BRAF V600E	Dabrafenib	Melanoma	FDA	label
BRAF V600E	Dabrafenib + trametinib	Paediatric low-grade glioma	FDA	label
BRAF V600E or V600K	Trametinib	Melanoma	FDA	label
BRAF V600E or V600K	Encorafenib	Melanoma	FDA	label
BRAF V600E	Vemurafenib	Melanoma	FDA	label
BRAF V600E FDA companion diagnostic rows for therascreen BRAF V600E RGQ PCR (P190026), FoundationOne Liquid CDx and Guardant360 CDx with Braftovi in combination with cetuximab in colorectal cancer.	Encorafenib	Colorectal cancer	FDA	label

Drugs whose label names it

Dabrafenib Dabrafenib + trametinib Trametinib Encorafenib Vemurafenib

Companion diagnostics (FDA list)

Device	Maker	Indication and sample	Drug	PMA / 510(k)
cobas 4800 BRAF V600 Mutation Test	Roche Molecular Systems	Melanoma - Tissue	Vemurafenib	P110020 (08/17/2011)
THxID BRAF Kit	bioMérieux	Melanoma - Tissue	Dabrafenib Trametinib	P120014 (05/29/2013)
THxID BRAF Kit	bioMérieux	Melanoma - Tissue	Encorafenib Binimetinib	P120014/S008 (06/27/2018)
therascreen BRAF V600E RGQ PCR Kit	QIAGEN	Colorectal Cancer - Tissue	Encorafenib Cetuximab	P190026 (04/15/2020)
Oncomine Dx Target Test	Life Technologies (Thermo Fisher Scientific)	Non-Small Cell Lung Cancer (NSCLC) - Tissue	Dabrafenib Trametinib	P160045 (06/22/2017)
Oncomine Dx Target Test	Life Technologies (Thermo Fisher Scientific)	Anaplastic Thyroid Cancer (ATC) - Tissue	Dabrafenib Trametinib	P160045/S025 (09/29/2023)
FoundationOne CDx	Foundation Medicine	Non-Small Cell Lung Cancer (NSCLC) - Tissue	Encorafenib Binimetinib	P170019/S039 (10/11/2023)
Guardant360 CDx	Guardant Health	Colorectal Cancer (CRC) - Plasma	Encorafenib Cetuximab	P200010/S026 (01/15/2026)

Tests that measure it

cobas 4800 BRAF V600 Mutation Test THxID BRAF Kit therascreen BRAF V600E RGQ PCR Kit Oncomine Dx Target Test Tempus xT and xT CDx FoundationOne CDx FoundationOne Liquid CDx Caris MI Cancer Seek Guardant360 CDx Illumina TruSight Oncology Comprehensive

Trials that name this readout

Matched on the name and aliases of the readout in the title, setting and summary of each trial; a match is a mention, not proof the readout was an entry criterion.