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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.
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.
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.
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| 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 |
| 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 | DabrafenibTrametinib | P120014 (05/29/2013) |
| THxID BRAF Kit | bioMérieux | Melanoma - Tissue | EncorafenibBinimetinib | P120014/S008 (06/27/2018) |
| therascreen BRAF V600E RGQ PCR Kit | QIAGEN | Colorectal Cancer - Tissue | EncorafenibCetuximab | P190026 (04/15/2020) |
| Oncomine Dx Target Test | Life Technologies (Thermo Fisher Scientific) | Non-Small Cell Lung Cancer (NSCLC) - Tissue | DabrafenibTrametinib | P160045 (06/22/2017) |
| Oncomine Dx Target Test | Life Technologies (Thermo Fisher Scientific) | Anaplastic Thyroid Cancer (ATC) - Tissue | DabrafenibTrametinib | P160045/S025 (09/29/2023) |
| FoundationOne CDx | Foundation Medicine | Non-Small Cell Lung Cancer (NSCLC) - Tissue | EncorafenibBinimetinib | P170019/S039 (10/11/2023) |
| Guardant360 CDx | Guardant Health | Colorectal Cancer (CRC) - Plasma | EncorafenibCetuximab | P200010/S026 (01/15/2026) |
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.
Patients with newly diagnosed metastatic colorectal cancer whose tumour carries a BRAF V600E mutation, which is about 8-12% of cases, should now be offered encorafenib and cetuximab together with FOLFOX from the start rather than after chemotherapy fails; median survival has roughly doubled to about two and a half years. BRAF testing at diagnosis is therefore essential, alongside RAS and mismatch repair testing. The regimen is more toxic than chemotherapy alone.
The reference Western cohort for gallbladder cancer frequencies, deposited on cBioPortal as gbc_mskcc_2022, where the per-gene sample counts on OnCo were read. It supports panel testing at diagnosis: one patient in three has a targetable finding.
Encorafenib with cetuximab became the standard second-line treatment for BRAF V600E disease, and the platform BREAKWATER later moved into first line with chemotherapy added, doubling survival again.
It stops a BRAF-mutant report being read as one uniform outlook, and it separates the class II and III mutations, which signal differently and are not covered by the encorafenib plus cetuximab label, from V600E.
It fixes the metastatic prevalence figures every subsequent trial design has used, and it separates two biomarkers that travel together: BRAF, not mismatch repair deficiency, is what makes the prognosis bad.
It is the study that made multiplex testing standard practice in lung adenocarcinoma, by showing both that most tumours have a driver and that finding it changes what patients receive.
It is the molecular definition of the serrated route and the reason BRAF V600E is used as a practical surrogate for sporadic rather than inherited MLH1 loss.
Shares therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF), KRAS G12C, RAS wild-type (extended KRAS and NRAS testing), Cetuximab and the tag biomarker.
Shares Non-V600 BRAF mutations define a clinically distinct molecular subtype of metastatic colorectal cancer, Encorafenib, binimetinib, and cetuximab in BRAF V600E-mutated colorectal cancer (BEACON CRC), BREAKWATER: encorafenib plus cetuximab with chemotherapy as first treatment for BRAF V600E-mutated colorectal cancer, Encorafenib and the tag braf.
Shares Comprehensive molecular characterization of gallbladder carcinoma and potential targets for intervention, Tumour-agnostic (tissue-agnostic) approval, Thyroid cancer, Gallbladder cancer and the tag biomarker.
Shares Comprehensive molecular characterization of gallbladder carcinoma and potential targets for intervention, Tumour-agnostic (tissue-agnostic) approval, Next-generation sequencing (NGS), Gallbladder cancer and the tag biomarker.
Shares Mismatch repair status and BRAF mutation status in metastatic colorectal cancer: a pooled analysis of the CAIRO, CAIRO2, COIN and FOCUS studies, Comprehensive molecular characterization of gallbladder carcinoma and potential targets for intervention, Tumour-agnostic (tissue-agnostic) approval, Next-generation sequencing (NGS) and the tag biomarker.
Shares Tumour-agnostic (tissue-agnostic) approval, Thyroid cancer, Metastatic cancer (cancer that has spread), Colorectal cancer and the tag biomarker.
Shares Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs, Next-generation sequencing (NGS), Gallbladder cancer, Non-small-cell lung cancer and the tag biomarker.
Shares therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF), Next-generation sequencing (NGS), Colorectal cancer, Non-small-cell lung cancer and the tag biomarker.