Tafinlar FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 7, 2020.
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
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