{"entity":{"id":"braf-v600e","kind":"biomarker","name":"BRAF V600E (and V600K)","aka":["BRAF V600E","V600E","BRAF V600","BRAF V600K","BRAF-mutant","BRAF class I mutation","BRAF V600E-mutant"],"tldr":"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.","summary":"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.","asOf":"2026-09-23","links":[{"label":"Tafinlar prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea"},{"label":"BRAFTOVI prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=235dfc38-0f0b-4037-b501-7a9f4294740c"}],"tags":["biomarker","braf"],"related":["braf-class-ii-iii","braf-fusion","kras-g12c"],"cancers":["melanoma","advanced-melanoma","colorectal","nsclc","thyroid","anaplastic-thyroid-cancer","paediatric-low-grade-glioma","metastatic-cancer","gallbladder"],"sections":[],"technologies":[],"targets":[],"drugs":["dabrafenib","trametinib","dabrafenib-trametinib","vemurafenib","cobimetinib","encorafenib","binimetinib","cetuximab","therascreen-cdx"],"companies":[],"institutions":[],"pathways":[],"terms":["braf-v600-mutation","ngs","tumour-agnostic"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-venderbosch-mmr-braf-metastatic-colorectal-pooled-ccr-2014","paper-weisenberger-cimp-braf-mlh1-colorectal-nat-genet-2006","paper-jones-non-v600-braf-colorectal-jco-2017","paper-kopetz-beacon-encorafenib-braf-colorectal-nejm-2019","paper-breakwater-nejm-2025","paper-giraldo-gallbladder-msk-impact-ccr-2022","paper-kris-lung-cancer-mutation-consortium-jama-2014"],"journals":[],"dependsOn":[],"notes":["Colorectal cancer: V600E in 6 to 18% by cohort and 8.2% of first-line metastatic patients; the threshold is simply the presence of the allele. It does three jobs here. It is prognostic (overall survival hazard ratio 1.91, and the shorter survival of mismatch repair deficiency is itself driven by co-occurring BRAF mutation; Venderbosch 2014). It is predictive, selecting encorafenib plus cetuximab, now first line with chemotherapy (BEACON CRC, BREAKWATER). And it is a reflex test in MLH1-deficient tumours, because BRAF V600E points to sporadic CIMP-associated methylation rather than Lynch syndrome (Weisenberger 2006). Non-V600 BRAF mutations, 22% of all BRAF mutations found, do not qualify for the regimen and carry a far better prognosis (Jones 2017).","Gallbladder cancer: BRAF mutation in 7 of 244 samples (2.9%) in cBioPortal gbc_mskcc_2022; the tumour-agnostic dabrafenib plus trametinib indication applies to V600E.","Lung cancer: 1 to 2% of adenocarcinomas, and, unlike in melanoma, a minority of all BRAF mutations found: 31 of 133 BRAF mutation records in the largest panel cohort and 9 of 45 in the TCGA adenocarcinomas (cBioPortal). A BRAF-mutant lung cancer therefore has to be read allele by allele before the licensed combination is considered."],"target":"braf","measurement":"sequencing-variant","scoringRule":{"text":"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.","quote":"V600E or V600K","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools","sourceLabel":"FDA: List of FDA-Authorized Companion Diagnostic Devices"},"thresholds":[{"value":"BRAF V600E","drugId":"dabrafenib","cancerId":"melanoma","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea","quote":"TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.","status":"current"},{"value":"BRAF V600E","drugId":"dabrafenib-trametinib","cancerId":"paediatric-low-grade-glioma","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea","quote":"TAFINLAR is indicated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy","status":"current"},{"value":"BRAF V600E or V600K","drugId":"trametinib","cancerId":"melanoma","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0002ad27-779d-42ab-83b5-bc65453412a1","quote":"MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.","status":"current"},{"value":"BRAF V600E or V600K","drugId":"encorafenib","cancerId":"melanoma","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=235dfc38-0f0b-4037-b501-7a9f4294740c","quote":"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-authorized test.","status":"current"},{"value":"BRAF V600E","drugId":"vemurafenib","cancerId":"melanoma","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38eea320-7e0c-485a-bc30-98c3c45e2763","quote":"ZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.","status":"current"},{"value":"BRAF V600E","drugId":"encorafenib","cancerId":"colorectal","regulator":"FDA","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools","quote":"BRAF V600E mutations","status":"current","note":"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."}],"tests":["foundationone-cdx","foundationone-liquid-cdx","guardant360-cdx","caris-mi-cancer-seek","tempus-xt","trusight-oncology-comprehensive"],"assays":["braf-cobas","braf-thxid","braf-therascreen","oncomine-dx"],"companionDiagnostics":[{"device":"cobas 4800 BRAF V600 Mutation Test","maker":"Roche Molecular Systems","drugs":["vemurafenib"],"indication":"Melanoma - Tissue","pma":"P110020 (08/17/2011)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"THxID BRAF Kit","maker":"bioMérieux","drugs":["dabrafenib","trametinib"],"indication":"Melanoma - Tissue","pma":"P120014 (05/29/2013)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"THxID BRAF Kit","maker":"bioMérieux","drugs":["encorafenib","binimetinib"],"indication":"Melanoma - Tissue","pma":"P120014/S008 (06/27/2018)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"therascreen BRAF V600E RGQ PCR Kit","maker":"QIAGEN","companyId":"qiagen","drugs":["encorafenib","cetuximab"],"indication":"Colorectal Cancer - Tissue","pma":"P190026 (04/15/2020)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"Oncomine Dx Target Test","maker":"Life Technologies (Thermo Fisher Scientific)","companyId":"thermo-fisher","drugs":["dabrafenib","trametinib"],"indication":"Non-Small Cell Lung Cancer (NSCLC) - Tissue","pma":"P160045 (06/22/2017)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"Oncomine Dx Target Test","maker":"Life Technologies (Thermo Fisher Scientific)","companyId":"thermo-fisher","drugs":["dabrafenib","trametinib"],"indication":"Anaplastic Thyroid Cancer (ATC) - Tissue","pma":"P160045/S025 (09/29/2023)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"FoundationOne CDx","maker":"Foundation Medicine","companyId":"foundation-medicine","drugs":["encorafenib","binimetinib"],"indication":"Non-Small Cell Lung Cancer (NSCLC) - Tissue","pma":"P170019/S039 (10/11/2023)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"Guardant360 CDx","maker":"Guardant Health","companyId":"guardant-health","drugs":["encorafenib","cetuximab"],"indication":"Colorectal Cancer (CRC) - Plasma","pma":"P200010/S026 (01/15/2026)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"forPatient":"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."},"route":"/biomarkers/braf-v600e/","neighbours":{"biomarker":[{"id":"braf-class-ii-iii","kind":"biomarker","name":"BRAF class II and class III mutations (non-V600)","route":"/biomarkers/braf-class-ii-iii/"},{"id":"braf-fusion","kind":"biomarker","name":"BRAF fusion or rearrangement","route":"/biomarkers/braf-fusion/"},{"id":"kras-g12c","kind":"biomarker","name":"KRAS G12C","route":"/biomarkers/kras-g12c/"},{"id":"ras-wild-type","kind":"biomarker","name":"RAS wild-type (extended KRAS and NRAS testing)","route":"/biomarkers/ras-wild-type/"}],"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"anaplastic-thyroid-cancer","kind":"cancer","name":"Anaplastic thyroid cancer","route":"/cancers/anaplastic-thyroid-cancer/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"paediatric-low-grade-glioma","kind":"cancer","name":"Paediatric low-grade glioma","route":"/cancers/paediatric-low-grade-glioma/"},{"id":"thyroid","kind":"cancer","name":"Thyroid cancer","route":"/cancers/thyroid/"}],"drug":[{"id":"binimetinib","kind":"drug","name":"Binimetinib","route":"/drugs/binimetinib/"},{"id":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"},{"id":"cobimetinib","kind":"drug","name":"Cobimetinib","route":"/drugs/cobimetinib/"},{"id":"dabrafenib","kind":"drug","name":"Dabrafenib","route":"/drugs/dabrafenib/"},{"id":"dabrafenib-trametinib","kind":"drug","name":"Dabrafenib + trametinib","route":"/drugs/dabrafenib-trametinib/"},{"id":"encorafenib","kind":"drug","name":"Encorafenib","route":"/drugs/encorafenib/"},{"id":"therascreen-cdx","kind":"drug","name":"therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF)","route":"/drugs/therascreen-cdx/"},{"id":"trametinib","kind":"drug","name":"Trametinib","route":"/drugs/trametinib/"},{"id":"vemurafenib","kind":"drug","name":"Vemurafenib","route":"/drugs/vemurafenib/"}],"term":[{"id":"braf-v600-mutation","kind":"term","name":"BRAF V600E mutation","route":"/terms/braf-v600-mutation/"},{"id":"ngs","kind":"term","name":"Next-generation sequencing (NGS)","route":"/terms/ngs/"},{"id":"tumour-agnostic","kind":"term","name":"Tumour-agnostic (tissue-agnostic) approval","route":"/terms/tumour-agnostic/"}],"paper":[{"id":"paper-breakwater-nejm-2025","kind":"paper","name":"BREAKWATER: encorafenib plus cetuximab with chemotherapy as first treatment for BRAF V600E-mutated colorectal cancer","route":"/key-papers/paper-breakwater-nejm-2025/"},{"id":"paper-giraldo-gallbladder-msk-impact-ccr-2022","kind":"paper","name":"Comprehensive molecular characterization of gallbladder carcinoma and potential targets for intervention","route":"/key-papers/paper-giraldo-gallbladder-msk-impact-ccr-2022/"},{"id":"paper-weisenberger-cimp-braf-mlh1-colorectal-nat-genet-2006","kind":"paper","name":"CpG island methylator phenotype underlies sporadic microsatellite instability and is tightly associated with BRAF mutation in colorectal cancer","route":"/key-papers/paper-weisenberger-cimp-braf-mlh1-colorectal-nat-genet-2006/"},{"id":"paper-kopetz-beacon-encorafenib-braf-colorectal-nejm-2019","kind":"paper","name":"Encorafenib, binimetinib, and cetuximab in BRAF V600E-mutated colorectal cancer (BEACON CRC)","route":"/key-papers/paper-kopetz-beacon-encorafenib-braf-colorectal-nejm-2019/"},{"id":"paper-venderbosch-mmr-braf-metastatic-colorectal-pooled-ccr-2014","kind":"paper","name":"Mismatch repair status and BRAF mutation status in metastatic colorectal cancer: a pooled analysis of the CAIRO, CAIRO2, COIN and FOCUS studies","route":"/key-papers/paper-venderbosch-mmr-braf-metastatic-colorectal-pooled-ccr-2014/"},{"id":"paper-jones-non-v600-braf-colorectal-jco-2017","kind":"paper","name":"Non-V600 BRAF mutations define a clinically distinct molecular subtype of metastatic colorectal cancer","route":"/key-papers/paper-jones-non-v600-braf-colorectal-jco-2017/"},{"id":"paper-kris-lung-cancer-mutation-consortium-jama-2014","kind":"paper","name":"Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs","route":"/key-papers/paper-kris-lung-cancer-mutation-consortium-jama-2014/"}],"target":[{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"}]}}