# Dabrafenib

Source: https://onco.cc/drugs/dabrafenib/  
OnCo record `dabrafenib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: nci-list
- 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: US 2013: BRAF V600E unresectable or metastatic melanoma (single agent); US 2014: 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; EU 2013: BRAF V600 melanoma; later NSCLC and adjuvant melanoma with trametinib

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Dabrafenib
- US label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=dabrafenib
- NCI drug page: https://www.cancer.gov/about-cancer/treatment/drugs/dabrafenib
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tafinlar

## Connected records

- drugs: [Dabrafenib + trametinib](https://onco.cc/drugs/dabrafenib-trametinib/), [Trametinib](https://onco.cc/drugs/trametinib/)
- biomarkers: [BRAF V600E (and V600K)](https://onco.cc/biomarkers/braf-v600e/)
- cancers: [Anaplastic thyroid cancer](https://onco.cc/cancers/anaplastic-thyroid-cancer/), [BRAF V600-mutant melanoma](https://onco.cc/cancers/braf-v600-melanoma/), [BRAF V600E-mutant non-small-cell lung cancer](https://onco.cc/cancers/braf-v600e-nsclc/), [Brain and spinal cord tumours (all types)](https://onco.cc/cancers/brain-tumours/), [Conjunctival melanoma](https://onco.cc/cancers/conjunctival-melanoma/), [Follicular thyroid cancer](https://onco.cc/cancers/follicular-thyroid-cancer/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Melanoma](https://onco.cc/cancers/melanoma/), [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Optic pathway glioma](https://onco.cc/cancers/optic-pathway-glioma/), [Paediatric high-grade glioma (excluding diffuse midline glioma)](https://onco.cc/cancers/paediatric-high-grade-glioma/), [Paediatric low-grade glioma](https://onco.cc/cancers/paediatric-low-grade-glioma/), [Papillary thyroid cancer](https://onco.cc/cancers/papillary-thyroid-cancer/), [Skin cancer (all types)](https://onco.cc/cancers/skin-cancer/), [Stage III melanoma (after surgery)](https://onco.cc/cancers/stage-iii-melanoma/), [Thyroid cancer](https://onco.cc/cancers/thyroid/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [BRAF](https://onco.cc/targets/braf/)
- companies: [Novartis](https://onco.cc/companies/novartis/)
- pathways: [Glioma (KEGG map)](https://onco.cc/pathways/glioma-signalling/), [Melanoma (KEGG map)](https://onco.cc/pathways/melanoma-signalling/), [Non-small cell lung cancer (KEGG map)](https://onco.cc/pathways/nsclc-signalling/), [RAS / RAF / MEK / ERK (MAPK)](https://onco.cc/pathways/ras-mapk/), [Thyroid cancer (KEGG map)](https://onco.cc/pathways/thyroid-cancer-signalling/)
- trials: [A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors](https://onco.cc/trials/nct05585320/), [A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colo](https://onco.cc/trials/nct07506109/), [BRF113928 cohort C (dabrafenib with trametinib, untreated BRAF V600E)](https://onco.cc/trials/brf113928/), [COMBI-AD](https://onco.cc/trials/combi-ad/), [COMBI-d](https://onco.cc/trials/combi-d/), [DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positi](https://onco.cc/trials/nct07440290/), [NCI-MATCH (EAY131)](https://onco.cc/trials/nci-match/), [ROAR (Rare Oncology Agnostic Research) basket: BRAF V600E biliary tract cancer cohort](https://onco.cc/trials/roar/), [Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refracto](https://onco.cc/trials/nct04940052/)
- key papers: [COMBI-AD: adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma](https://onco.cc/key-papers/paper-combi-ad-nejm-2017/), [COMBI-d: dabrafenib and trametinib versus dabrafenib alone for BRAF V600-mutant melanoma](https://onco.cc/key-papers/paper-combi-d-long-lancet-2015/), [Dabrafenib and trametinib in BRAF V600E-mutant anaplastic thyroid cancer (ROAR)](https://onco.cc/key-papers/paper-subbiah-dabrafenib-trametinib-atc-jco-2018/), [Dabrafenib plus trametinib in previously treated BRAF V600E-mutant metastatic non-small-cell lung cancer](https://onco.cc/key-papers/paper-planchard-dabrafenib-trametinib-braf-nsclc-lancet-oncol-2016/), [Dabrafenib plus trametinib in previously untreated BRAF V600E-mutant metastatic non-small-cell lung cancer](https://onco.cc/key-papers/paper-planchard-dabrafenib-trametinib-first-line-lancet-oncol-2017/), [Dabrafenib plus trametinib in relapsed or refractory BRAF V600-mutant paediatric high-grade glioma](https://onco.cc/key-papers/paper-hargrave-dabrafenib-trametinib-paediatric-hgg-jco-2023/), [DREAMseq (ECOG-ACRIN EA6134): sequencing dabrafenib-trametinib and nivolumab-ipilimumab in BRAF-mutant metastatic melanoma](https://onco.cc/key-papers/paper-dreamseq-jco-2023/)
- terms: [Basket trial](https://onco.cc/terms/basket-trial/)

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