{"entity":{"id":"dabrafenib","kind":"drug","name":"Dabrafenib","aka":[],"tldr":"Dabrafenib (Tafinlar) is a capsule that switches off the faulty BRAF protein driving some melanomas, lung, thyroid and other cancers. It is almost always paired with trametinib.","summary":"Dabrafenib was approved by the FDA in May 2013 as a single agent for unresectable or metastatic BRAF V600E melanoma (BREAK-3: progression-free survival superior to dacarbazine) and in 2014 in combination with trametinib, which became the standard after COMBI-d and COMBI-v showed longer overall survival than single-agent BRAF inhibition. Later indications, all with trametinib: adjuvant stage III BRAF-mutant melanoma (COMBI-AD, 2018), BRAF V600E metastatic NSCLC (2017), anaplastic thyroid cancer (2018), tumour-agnostic BRAF V600E solid tumours (2022) and paediatric low-grade glioma with a dispersible tablet formulation (2023). The EU authorised Tafinlar in 2013. Pyrexia is the signature toxicity of the combination; cutaneous squamous cell carcinomas and hyperglycaemia occur with monotherapy.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Dabrafenib","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=dabrafenib"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/dabrafenib"},{"label":"EPAR","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tafinlar"}],"tags":["nci-list"],"related":["dabrafenib-trametinib","braf-v600e"],"cancers":["melanoma","nsclc","thyroid","anaplastic-thyroid-cancer","papillary-thyroid-cancer","paediatric-low-grade-glioma","paediatric-high-grade-glioma","braf-v600e-nsclc","braf-v600-melanoma","stage-iii-melanoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf"],"drugs":[],"companies":["novartis"],"institutions":[],"pathways":["ras-mapk"],"terms":[],"trials":["combi-ad","nct04940052","nct05585320"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Tafinlar","modality":"Small-molecule BRAF kinase inhibitor","mechanism":"ATP-competitive inhibitor of BRAF V600E, V600K and V600D kinases (and wild-type BRAF and CRAF at higher concentrations); blocks MAPK signalling in BRAF-mutant tumours.","approvals":[{"region":"US","year":2013,"indication":"BRAF V600E unresectable or metastatic melanoma (single agent)"},{"region":"US","year":2014,"indication":"With trametinib: BRAF V600E/K metastatic melanoma; later adjuvant melanoma, BRAF V600E NSCLC, anaplastic thyroid cancer, tumour-agnostic solid tumours and paediatric low-grade glioma"},{"region":"EU","year":2013,"indication":"BRAF V600 melanoma; later NSCLC and adjuvant melanoma with trametinib"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2014-01-09","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"In combination with trametinib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test"},{"date":"2015-11-20","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2014 converted to traditional approval 1.9 years after it was granted.","indication":"In combination with trametinib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test"},{"date":"2022-06-22","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 4.2 years later, when the FDA's table was read.","source":"https://www.fda.gov#endnote2","indication":"In combination with trametinib for adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. *"}]},"route":"/drugs/dabrafenib/","neighbours":{"drug":[{"id":"dabrafenib-trametinib","kind":"drug","name":"Dabrafenib + trametinib","route":"/drugs/dabrafenib-trametinib/"},{"id":"trametinib","kind":"drug","name":"Trametinib","route":"/drugs/trametinib/"}],"biomarker":[{"id":"braf-v600e","kind":"biomarker","name":"BRAF V600E (and V600K)","route":"/biomarkers/braf-v600e/"}],"cancer":[{"id":"anaplastic-thyroid-cancer","kind":"cancer","name":"Anaplastic thyroid cancer","route":"/cancers/anaplastic-thyroid-cancer/"},{"id":"braf-v600-melanoma","kind":"cancer","name":"BRAF V600-mutant melanoma","route":"/cancers/braf-v600-melanoma/"},{"id":"braf-v600e-nsclc","kind":"cancer","name":"BRAF V600E-mutant non-small-cell lung cancer","route":"/cancers/braf-v600e-nsclc/"},{"id":"brain-tumours","kind":"cancer","name":"Brain and spinal cord tumours (all types)","route":"/cancers/brain-tumours/"},{"id":"conjunctival-melanoma","kind":"cancer","name":"Conjunctival melanoma","route":"/cancers/conjunctival-melanoma/"},{"id":"follicular-thyroid-cancer","kind":"cancer","name":"Follicular thyroid cancer","route":"/cancers/follicular-thyroid-cancer/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"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":"optic-pathway-glioma","kind":"cancer","name":"Optic pathway glioma","route":"/cancers/optic-pathway-glioma/"},{"id":"paediatric-high-grade-glioma","kind":"cancer","name":"Paediatric high-grade glioma (excluding diffuse midline glioma)","route":"/cancers/paediatric-high-grade-glioma/"},{"id":"paediatric-low-grade-glioma","kind":"cancer","name":"Paediatric low-grade glioma","route":"/cancers/paediatric-low-grade-glioma/"},{"id":"papillary-thyroid-cancer","kind":"cancer","name":"Papillary thyroid cancer","route":"/cancers/papillary-thyroid-cancer/"},{"id":"skin-cancer","kind":"cancer","name":"Skin cancer (all types)","route":"/cancers/skin-cancer/"},{"id":"stage-iii-melanoma","kind":"cancer","name":"Stage III melanoma (after surgery)","route":"/cancers/stage-iii-melanoma/"},{"id":"thyroid","kind":"cancer","name":"Thyroid cancer","route":"/cancers/thyroid/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}],"pathway":[{"id":"glioma-signalling","kind":"pathway","name":"Glioma (KEGG map)","route":"/pathways/glioma-signalling/"},{"id":"melanoma-signalling","kind":"pathway","name":"Melanoma (KEGG map)","route":"/pathways/melanoma-signalling/"},{"id":"nsclc-signalling","kind":"pathway","name":"Non-small cell lung cancer (KEGG map)","route":"/pathways/nsclc-signalling/"},{"id":"ras-mapk","kind":"pathway","name":"RAS / RAF / MEK / ERK (MAPK)","route":"/pathways/ras-mapk/"},{"id":"thyroid-cancer-signalling","kind":"pathway","name":"Thyroid cancer (KEGG map)","route":"/pathways/thyroid-cancer-signalling/"}],"trial":[{"id":"nct05585320","kind":"trial","name":"A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors","route":"/trials/nct05585320/"},{"id":"nct07506109","kind":"trial","name":"A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colo","route":"/trials/nct07506109/"},{"id":"brf113928","kind":"trial","name":"BRF113928 cohort C (dabrafenib with trametinib, untreated BRAF V600E)","route":"/trials/brf113928/"},{"id":"combi-ad","kind":"trial","name":"COMBI-AD","route":"/trials/combi-ad/"},{"id":"combi-d","kind":"trial","name":"COMBI-d","route":"/trials/combi-d/"},{"id":"nct07440290","kind":"trial","name":"DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positi","route":"/trials/nct07440290/"},{"id":"nci-match","kind":"trial","name":"NCI-MATCH (EAY131)","route":"/trials/nci-match/"},{"id":"roar","kind":"trial","name":"ROAR (Rare Oncology Agnostic Research) basket: BRAF V600E biliary tract cancer cohort","route":"/trials/roar/"},{"id":"nct04940052","kind":"trial","name":"Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refracto","route":"/trials/nct04940052/"}],"paper":[{"id":"paper-combi-ad-nejm-2017","kind":"paper","name":"COMBI-AD: adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma","route":"/key-papers/paper-combi-ad-nejm-2017/"},{"id":"paper-combi-d-long-lancet-2015","kind":"paper","name":"COMBI-d: dabrafenib and trametinib versus dabrafenib alone for BRAF V600-mutant melanoma","route":"/key-papers/paper-combi-d-long-lancet-2015/"},{"id":"paper-subbiah-dabrafenib-trametinib-atc-jco-2018","kind":"paper","name":"Dabrafenib and trametinib in BRAF V600E-mutant anaplastic thyroid cancer (ROAR)","route":"/key-papers/paper-subbiah-dabrafenib-trametinib-atc-jco-2018/"},{"id":"paper-planchard-dabrafenib-trametinib-braf-nsclc-lancet-oncol-2016","kind":"paper","name":"Dabrafenib plus trametinib in previously treated BRAF V600E-mutant metastatic non-small-cell lung cancer","route":"/key-papers/paper-planchard-dabrafenib-trametinib-braf-nsclc-lancet-oncol-2016/"},{"id":"paper-planchard-dabrafenib-trametinib-first-line-lancet-oncol-2017","kind":"paper","name":"Dabrafenib plus trametinib in previously untreated BRAF V600E-mutant metastatic non-small-cell lung cancer","route":"/key-papers/paper-planchard-dabrafenib-trametinib-first-line-lancet-oncol-2017/"},{"id":"paper-hargrave-dabrafenib-trametinib-paediatric-hgg-jco-2023","kind":"paper","name":"Dabrafenib plus trametinib in relapsed or refractory BRAF V600-mutant paediatric high-grade glioma","route":"/key-papers/paper-hargrave-dabrafenib-trametinib-paediatric-hgg-jco-2023/"},{"id":"paper-dreamseq-jco-2023","kind":"paper","name":"DREAMseq (ECOG-ACRIN EA6134): sequencing dabrafenib-trametinib and nivolumab-ipilimumab in BRAF-mutant metastatic melanoma","route":"/key-papers/paper-dreamseq-jco-2023/"}],"term":[{"id":"basket-trial","kind":"term","name":"Basket trial","route":"/terms/basket-trial/"}]}}