NDAORALCAPSULE
Approved
May 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
38
Data completeness
3/8 — Basic
Drug data last refreshed 3d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TAFINLAR (dabrafenib) is an oral small-molecule BRAF kinase inhibitor approved in 2013 for BRAF V600-mutant melanoma and non-small cell lung cancer. It works by inhibiting constitutively activated BRAF kinases that drive tumor cell growth in patients with specific BRAF mutations. The drug is typically used as part of combination therapy with MEK inhibitors like trametinib to improve efficacy and delay resistance.
Peak7.8 years to LOE
TAFINLAR is at peak lifecycle with $147M in annual spending, indicating a mature, stable commercial team managing a well-established franchise.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (38)
DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers.
Started Feb 2026
30 enrolled
Haematological MalignancyMalignant NeoplasmLymphoproliferative Disorders+16 more
Special Drug Use-results Surveillance of Tafinlar/Mekinist
Started Feb 2024
110 enrolled
BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor
Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
Started Feb 2024
40 enrolled
Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors
NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)
Started Jan 2023
20 enrolled
Anaplastic Thyroid Cancer
Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy in Patients With BRAF V600-mutated Stage III/IV Melanoma
Started Oct 2022
38 enrolled
BRAF V600 Mutated-Stage III/IV Melanoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.