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
NCT07440290

DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers.

RECRUITING PHASE2/PHASE3
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
NCT04675710

Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer

ACTIVE_NOT_RECRUITING PHASE2
NCT04238624

Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer

ACTIVE_NOT_RECRUITING PHASE2
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

ACTIVE_NOT_RECRUITING PHASE4
NCT03340506

Dabrafenib and/or Trametinib Rollover Study

RECRUITING PHASE4
NCT03149029

Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma

ACTIVE_NOT_RECRUITING PHASE2