Drug glossary Targeted therapy

Dabrafenib Tafinlar

Used in colorectal cancer outside its approved indication. It appears in 9 clinical trials.

Oral BRAF V600E

United States Off-label

European Union EMA approved Since 2013

Spain Hospital use Used off-label in colorectal cancer

What it is

Dabrafenib is a selective BRAF kinase inhibitor used in the treatment of metastatic colorectal cancer harboring BRAF V600E mutations. This targeted therapy is employed in combination regimens with other agents such as anti-EGFR antibodies (cetuximab or panitumumab) and chemotherapy backbones like FOLFOX for patients with advanced disease. Dabrafenib specifically addresses the therapeutic challenge posed by BRAF-mutated colorectal cancers, which represent approximately 8-15% of metastatic cases and historically demonstrate poor response to standard treatments.

How it works

Dabrafenib selectively inhibits mutant BRAF V600E kinase, blocking aberrant MAPK pathway signaling that drives tumor cell proliferation and survival. By targeting this specific oncogenic mutation, the drug disrupts the downstream cascade of cellular signals that promote cancer growth and metastasis.

Molecular targets

BRAF V600E

Common side effects

PyrexiaFatigueHyperkeratosisPapillomaAlopeciaPalmar-plantar erythrodysesthesia syndromeDecreased appetiteArthralgia

Not all are listed, and everyone experiences them differently. If you notice any, tell your care team.

Trials with this drug

3 recruiting

DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancer… NCT07440290 Recruiting Phase 2 United Kingdom A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Ca… NCT07506109 Recruiting Phase 2 China A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer NCT06978400 Recruiting Phase 2 Russia A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors NCT05585320 Active, not recruiting Phase 1 United States A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer NCT04294160 Archived Phase 1 United States, Australia, Belgium and 7 more JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations NCT04418167 Suspended Phase 1 United States

See all 9 trials

At a glance

Brand name: Tafinlar
Type: Targeted therapy
Route: Oral
Approved (FDA): 2013
Trials: 9 (3 recruiting)

Related drugs

EncorafenibTargeted therapy26 trials VemurafenibTargeted therapy17 trials HLX208Drug2 trials RegorafenibTargeted therapy109 trials FruquintinibTargeted therapy62 trials BinimetinibTargeted therapy22 trials

Medical notice

This information is for educational purposes only and should not replace professional medical advice. Always consult your healthcare team before making treatment decisions.

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