dabrafenib
Dabrafenib (Tafinlar) is a BRAF kinase inhibitor used to treat certain melanomas, lung cancers, thyroid cancers, and other solid tumors with BRAF V600 mutations. It blocks the abnormal BRAF protein that signals cancer cells to grow and divide. It is used alone or in combination with trametinib.
This page is based on EMA and FDA prescribing information for dabrafenib capsules, cross-checked with DailyMed and MedlinePlus; the mechanism is explained in plain language, and analogies are used only where they stay accurate.
How it works
Explains what the medicine does in the body, not dosing, side effects, or safety.
An analogy
Cancer cells with a BRAF V600 mutation have a stuck accelerator pedal that tells them to grow nonstop. Dabrafenib acts like a block under that pedal, preventing the signal from reaching the cell's growth machinery. When combined with trametinib, which blocks the next step in the same pathway, the cancer cell receives two brakes instead of one.
In simple terms
Dabrafenib blocks the action of an abnormal BRAF protein found in certain cancer cells. This protein normally helps cells grow and divide, but when it is mutated (changed), it stays turned on and tells cancer cells to multiply uncontrollably. By blocking this abnormal protein, dabrafenib helps slow or stop the growth of cancer cells. It is used to treat certain types of melanoma, lung cancer, thyroid cancer, and other solid tumors that have the BRAF V600 mutation. Dabrafenib is often combined with trametinib, which blocks a different protein in the same growth pathway, to provide stronger control of cancer growth.
In depth
Dabrafenib is a selective inhibitor of the BRAF V600E and V600K mutant kinases. The BRAF V600 mutation results in constitutive activation of the RAF-MEK-ERK signaling pathway (MAPK/ERK pathway), driving uncontrolled cellular proliferation and survival. Dabrafenib binds to the ATP-binding site of the mutant BRAF kinase, inhibiting its activity and downstream signaling. When combined with trametinib (a MEK inhibitor), dual blockade of the MAPK pathway provides enhanced antitumor activity and delays resistance compared to BRAF inhibition alone. Dabrafenib is not active against wild-type BRAF and should not be used in tumors without BRAF V600 mutations.
See it in motion
A schematic animation of the mechanism — simplified for clarity, not drawn to scale.
Cancer cells with a BRAF V600 mutation have a stuck accelerator pedal that tells them to grow nonstop.
- Dabrafenib blocks the action of an abnormal BRAF protein found in certain cancer cells.
- This protein normally helps cells grow and divide, but when it is mutated (changed), it stays turned on and tells cancer cells to multiply uncontrollably.
- Dabrafenib acts like a block under that pedal, preventing the signal from reaching the cell's growth machinery.
- When combined with trametinib, which blocks the next step in the same pathway, the cancer cell receives two brakes instead of one.
Target: BRAF V600E/K mutant kinase
A mutated form of the BRAF serine/threonine kinase that signals continuously through the MAPK pathway, driving cancer cell growth and division.
Approved uses
Approved uses differ by country and change over time. Always follow your local prescribing information.
Approved uses in European Union
EMA- Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation
- Adjuvant treatment of melanoma: Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection
- Non-small cell lung cancer (NSCLC): Dabrafenib in combination with trametinib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation
- Differentiated thyroid cancer (DTC): Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy
Approved uses in United States
FDA- TAFINLAR is 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
- TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test
- TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection
- TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test
- TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options
- TAFINLAR is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 1 year 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
- 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
Approved uses in United States
DailyMed- TAFINLAR is 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
- TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test
- TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection
- TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test
- TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options
- TAFINLAR is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 1 year 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
- 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
Official sources
The statements on this page trace back to these records.
- Tafinlar (dabrafenib) — Summary of product characteristics and package leaflet, English version
European Medicines Agency
- U.S. Food and Drug Administration: dabrafenib prescribing information
U.S. Food and Drug Administration
- DailyMed: dabrafenib labeling
DailyMed, U.S. National Library of Medicine
- MedlinePlus: dabrafenib
MedlinePlus, U.S. National Library of Medicine
This page explains how the medicine works — it isn’t the patient leaflet. For anything that applies to you, read the leaflet that came with your medicine or ask your pharmacist.
MedUnfold provides educational content and is not medical advice. Always follow your local prescribing information and healthcare professional.