Dabrafenib (Tafinlar)

Targeted Therapy · Approved since 2013

US Off-label EU EMA Approved ES Hospital use off-label in CRC Oral 9 Clinical Trials
BRAF V600E

Description

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.

Mechanism of Action

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

Side Effects

Pyrexia Fatigue Hyperkeratosis Papilloma Alopecia Palmar-plantar erythrodysesthesia syndrome Decreased appetite Arthralgia

Not all side effects are listed. Side effects vary by individual. Always consult your oncologist.

Clinical Trials

NCT07506109 Phase 2
Recruiting
A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer
China
NCT06978400 Phase 2
Recruiting
A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer
Russia
NCT07440290 Phase 2
Not yet recruiting
DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers.
United Kingdom
NCT05585320 Phase 1
Active, not recruiting
A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors
United States
NCT04294160 Phase 1
Terminated
A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer
United States, Australia, Belgium, Canada, Germany, Israel, Netherlands, Singapo
NCT04418167 Phase 1
Suspended
JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations
United States
View all 9 clinical trials →