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 Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TAFINLAR (dabrafenib) is an oral small-molecule BRAF inhibitor approved by the FDA on March 16, 2023, for treatment of BRAF V600E/K-mutant cancers across multiple indications. The drug is indicated for melanoma, non-small cell lung cancer, colorectal cancer, thyroid cancer, gliomas (including glioblastoma and astrocytoma), and hematologic malignancies including various leukemias and lymphomas, among others. Dabrafenib works by inhibiting mutant BRAF kinase, blocking a key driver of cell proliferation in BRAF-mutant tumors. It is often used as monotherapy or in combination with MEK inhibitors like trametinib to overcome resistance mechanisms.
$0.1BPart D
12.7 years to LOEMechanism 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
Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma
Started Jun 2022
30 enrolled
Metastatic MelanomaBRAF Gene Mutation
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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.