Tafinlar FDA Approval History
FDA Approved: Yes (First approved May 29, 2013)
Brand name: Tafinlar
Generic name: dabrafenib
Dosage form: Capsules
Treatment for: Melanoma, Metastatic, Non-Small Cell Lung Cancer, Thyroid Cancer
Tafinlar is also indicated, in combination with trametinib (Mekinist), for:
- the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
- the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
- the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
- the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.
Development Timeline for Tafinlar
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.