# Dabrafenib + trametinib

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

## TL;DR

Dabrafenib plus trametinib is the BRAF-plus-MEK pill combination, approved for BRAF V600E lung cancer and, since 2022, for any solid tumour with that mutation.

## Summary

Dabrafenib blocks BRAF V600 and trametinib is an allosteric MEK1/2 inhibitor; blocking two consecutive steps of the MAPK pathway (vertical blockade) prevents the paradoxical reactivation seen with BRAF inhibitors alone. In BRAF V600E non-small-cell lung cancer (about 2% of adenocarcinomas) the combination gave an ORR of 64% first line with median PFS of about 10.8 months (BRF113928), and it is an established doublet in BRAF-mutant melanoma and thyroid cancer. A tumour-agnostic approval followed in June 2022 for BRAF V600E solid tumours (excluding colorectal) in patients aged 6 and over. Pyrexia is the characteristic toxicity and the usual reason for dose interruptions. Encorafenib plus binimetinib (PHAROS, 2023) is the alternative doublet in lung cancer. In short, if a tumour carries BRAF V600E, this pair of pills is a treatment option in most tissue types.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-06
- Brand: Tafinlar + Mekinist
- Modality: Small-molecule kinase inhibitors (BRAF + MEK)
- Mechanism: BRAF V600 inhibitor plus allosteric MEK1/2 inhibitor; vertical blockade prevents paradoxical MAPK reactivation.
- Approvals: US 2014: BRAF V600E/K unresectable or metastatic melanoma, combination (accelerated; each drug alone approved 2013); US 2017: BRAF V600E metastatic NSCLC; US 2022: BRAF V600E solid tumours, tumour-agnostic (age ≥6); England (NICE) 2023: BRAF V600 mutation-positive advanced non-small-cell lung cancer, first line only

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Dabrafenib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Dabrafenib
- NICE TA898: dabrafenib plus trametinib for BRAF V600 mutation-positive advanced non-small-cell lung cancer: https://www.nice.org.uk/guidance/ta898

## Connected records

- pairings: [BRAF inhibitor + MEK inhibitor](https://onco.cc/pairings/braf-plus-mek/), [BRAF/MEK inhibition → surgery in anaplastic thyroid cancer](https://onco.cc/pairings/braf-mek-neoadjuvant-atc/), [Immunotherapy first, then BRAF/MEK (BRAF-mutant melanoma)](https://onco.cc/pairings/io-first-then-braf-mek/), [MAPK inhibitor redifferentiation → radioiodine](https://onco.cc/pairings/redifferentiation-rai/)
- biomarkers: [BRAF V600E (and V600K)](https://onco.cc/biomarkers/braf-v600e/)
- cancers: [Acral melanoma](https://onco.cc/cancers/acral-melanoma/), [Advanced melanoma (unresectable stage III and stage IV)](https://onco.cc/cancers/advanced-melanoma/), [Ampullary cancer (ampulla of Vater)](https://onco.cc/cancers/ampullary/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [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 metastases (secondary brain tumours)](https://onco.cc/cancers/secondary-brain-tumours/), [Craniopharyngioma](https://onco.cc/cancers/craniopharyngioma/), [Erdheim-Chester disease](https://onco.cc/cancers/erdheim-chester-disease/), [Erdheim-Chester disease, Rosai-Dorfman disease and other histiocytic neoplasms](https://onco.cc/cancers/histiocytoses/), [Extrahepatic cholangiocarcinoma (perihilar and distal)](https://onco.cc/cancers/extrahepatic-cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/), [Hairy cell leukaemia](https://onco.cc/cancers/hairy-cell-leukemia/), [KRAS wild-type pancreatic ductal adenocarcinoma](https://onco.cc/cancers/kras-wild-type-pdac/), [Langerhans cell histiocytosis (LCH)](https://onco.cc/cancers/langerhans-cell-histiocytosis/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Melanoma](https://onco.cc/cancers/melanoma/), [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/), [Multisystem Langerhans cell histiocytosis (with or without risk-organ involvement)](https://onco.cc/cancers/lch-multisystem/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [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/), [Pancreatic acinar cell carcinoma](https://onco.cc/cancers/pancreatic-acinar-cell-carcinoma/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Single-system Langerhans cell histiocytosis (bone, skin or one other organ)](https://onco.cc/cancers/lch-single-system/), [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: [RAS / RAF / MEK / ERK (MAPK)](https://onco.cc/pathways/ras-mapk/)
- terms: [Lung cancer drugs in England: what NICE has recommended](https://onco.cc/terms/lung-uk-drug-access/), [RACE for Children Act](https://onco.cc/terms/race-for-children-act/), [Tumour-agnostic (tissue-agnostic) approval](https://onco.cc/terms/tumour-agnostic/)
- trials: [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/), [DREAMseq (ECOG-ACRIN EA6134)](https://onco.cc/trials/dreamseq/), [PHAROS](https://onco.cc/trials/pharos/), [ROAR (anaplastic thyroid cancer cohort)](https://onco.cc/trials/roar-atc/), [ROAR (Rare Oncology Agnostic Research) basket: BRAF V600E biliary tract cancer cohort](https://onco.cc/trials/roar/), [TADPOLE (CDRB436G2201)](https://onco.cc/trials/tadpole/)
- ideas: [BRAF/MEK plus PD-1 blockade as standard for BRAF-mutant anaplastic thyroid cancer](https://onco.cc/ideas/idea-atc-triplet-io/)
- people: [Keith T. Flaherty](https://onco.cc/people/keith-flaherty/)
- drugs: [Dabrafenib](https://onco.cc/drugs/dabrafenib/), [Trametinib](https://onco.cc/drugs/trametinib/)
- roadmaps: [Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first](https://onco.cc/roadmaps/paediatric-oncology-roadmap/), [Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall](https://onco.cc/roadmaps/targeted-therapy-roadmap/)

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