Tafinlar Approval History
- FDA approved: Yes (First approved May 29th, 2013)
- Brand name: Tafinlar
- Generic name: dabrafenib
- Dosage form: Capsules
- Company: GlaxoSmithKline
- Treatment for: Melanoma, Metastatic, Non-Small Cell Lung Cancer, Thyroid Cancer
Tafinlar (dabrafenib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
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 History and FDA Approval Process for Tafinlar
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