Dabrafenib

Drug

Drug Profile

Dabrafenib is an oral kinase inhibitor marketed as Tafinlar for BRAF V600 mutation-positive cancers in specified settings, as monotherapy and frequently in combination with trametinib. U.S. labeling includes melanoma, NSCLC, anaplastic thyroid cancer, certain solid tumors, and pediatric low-grade glioma indications. Initial U.S. approval was in 2013.

Drug Class
Kinase inhibitor (BRAF-targeted therapy)
Approval Status
FDA approved (initial U.S. approval 2013; revised March 2026)
Brand Names
  • TAFINLAR
Indications
  • \BRAF V600E mutation-positive unresectable or metastatic melanoma (single-agent setting)\
  • \Multiple BRAF V600 mutation-positive cancers in combination with trametinib including melanoma, NSCLC, anaplastic thyroid cancer, selected solid tumors, and pediatric low-grade glioma\

Related News

Related Clinical Trials

NCT ID Title Status Phase
NCT07110246

Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas

RECRUITING PHASE2
NCT06475989

Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer

RECRUITING PHASE3
NCT04940052

Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer

ACTIVE_NOT_RECRUITING PHASE3
NCT04116541

A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

RECRUITING PHASE2
NCT03975829

Pediatric Long-Term Follow-up and Rollover Study

RECRUITING PHASE4
NCT03149029

Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma

ACTIVE_NOT_RECRUITING PHASE2
NCT02465060

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

ACTIVE_NOT_RECRUITING PHASE2
NCT01989585

Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma

ACTIVE_NOT_RECRUITING PHASE1/PHASE2
NCT01947023

Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery

ACTIVE_NOT_RECRUITING PHASE1
NCT01682083

Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

COMPLETED PHASE3