NDAORALCAPSULE
Approved
May 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TAFINLAR (dabrafenib) is an oral small-molecule BRAF kinase inhibitor approved by the FDA in May 2013 for the treatment of melanoma and other BRAF V600E/K-mutant cancers. It works by selectively inhibiting mutated BRAF protein, blocking the growth signaling pathway in cancer cells. The drug is typically used in combination with MEK inhibitors to enhance efficacy and overcome resistance.
Peak7.6 years to LOE
TAFINLAR is at peak commercial maturity with strong established market presence; brand teams focus on patient retention and indication expansion rather than growth-stage hiring.
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 (20)
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
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
A Study of Patient Characteristics and Treatment Patterns in Real-world Melanoma Patients Treated With Dabrafenib and Trametinib or Encorafenib and Binimetinib in Japan
Started Aug 2022
82 enrolled
Melanoma
Worked on TAFINLAR at Novartis? Share your interview experience or compensation data (+7 days Pro)
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.