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Tafinlar FDA Approval History

Last updated by Judith Stewart, BPharm on March 29, 2023.

FDA Approved: Yes (First approved May 29, 2013)
Brand name: Tafinlar
Generic name: dabrafenib
Dosage form: Capsules and Tablets for Oral Suspension
Company: Novartis Pharmaceuticals Corporation
Treatment for: Melanoma, Metastatic, Non Small Cell Lung Cancer, Thyroid Cancer, Solid Tumors, Low-Grade Glioma

Tafinlar (dabrafenib) is a kinase inhibitor for the treatment of melanoma, non-small cell lung cancer, thyroid cancer, solid tumors, and low-grade glioma with BRAF V600 mutations.

Tafinlar is an inhibitor of some mutated BRAF kinases, including the BRAF V600E and V600K mutations. Tafinlar is indicated:

Development timeline for Tafinlar

DateArticle
Mar 19, 2023Approval Novartis Tafinlar + Mekinist Approved by FDA for Pediatric Patients with BRAF V600E Low-Grade Glioma
Jun 23, 2022Approval Novartis Tafinlar + Mekinist Receives FDA Approval for First Tumor-Agnostic Indication for BRAF V600E Solid Tumors
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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