{"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"],"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":[],"journals":[],"dependsOn":[],"notes":[],"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/"}],"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":"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/"}],"target":[{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"}]}}