NDAORALCAPSULEPriority Review
Approved
Mar 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TAFINLAR (dabrafenib) is an oral small-molecule BRAF inhibitor approved by the FDA in March 2023 for the treatment of BRAF V600E/K mutation-positive melanoma and other solid tumors. It works by selectively inhibiting mutated BRAF kinase, blocking downstream signaling in cancer cells with activating BRAF mutations.
$147MPart D
Peak12.5 years to LOEStrong Medicare utilization at $147M spending (2023) signals established market presence; peak lifecycle suggests mature commercial infrastructure with stable team sizing.
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
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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.