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Tafinlar Approval History

FDA Approved: Yes (First approved May 29, 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

DateArticle
May  4, 2018Approval FDA Approves Tafinlar + Mekinist for the Treatment of BRAF-Positive Anaplastic Thyroid Cancer
Apr 30, 2018Approval Novartis Receives FDA Approval of Tafinlar + Mekinist for Adjuvant Treatment of BRAF V600-Mutant Melanoma
Jun 22, 2017Approval Novartis Combination Targeted Therapy Tafinlar + Mekinist Receives FDA Approval for BRAF V600E Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)
Jan  9, 2014Approval GSK Gains Accelerated FDA Approval for Combination Use of Mekinist (trametinib) and Tafinlar (dabrafenib)
May 29, 2013Approval FDA Approves Tafinlar (dabrafenib) for Advanced Melanoma

Further information

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