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Mekinist Approval History

FDA Approved: Yes (First approved May 29, 2013)
Brand name: Mekinist
Generic name: trametinib
Dosage form: Tablets
Company: GlaxoSmithKline
Treatment for: Melanoma, Metastatic, Non-Small Cell Lung Cancer, Thyroid Cancer

Mekinist (trametinib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

Mekinist is also indicated, in combination with dabrafenib (Tafinlar), 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 Mekinist

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 Mekinist (trametinib) for Advanced Melanoma
May  1, 2013Regulatory Update: Trametinib US PDUFA Date Extended to 3 September 2013

Further information

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