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Mekinist FDA Approval History

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

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

Mekinist (trametinib) 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.

Mekinist (trametinib) is an inhibitor of some mutated BRAF kinases, including the BRAF V600E and V600K mutations.
Mekinist is indicated:

  • as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
  •  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.
    •  the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
    • the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.
  • Mekinist tablets and oral solution are taken orally once daily least 1 hour before or at least 2 hours after a meal.
  • Warnings and precautions associated with Mekinist include new primary malignancies, hemorrhage, colitis and gastrointestinal perforation, venous thromboembolism, cardiomyopathy, ocular toxicities, interstitial lung disease (ILD), serious febrile reactions, serious skin toxicities, hyperglycemia, and embryo-fetal toxicity.
  • Common adverse reactions for Mekinist as a single agent include rash, diarrhea, and lymphedema.
    Common adverse reactions for Mekinist with dabrafenib include:
    • Unresectable or metastatic melanoma: pyrexia, nausea, rash, chills, diarrhea, vomiting, hypertension, and peripheral edema.
    • Adjuvant treatment of melanoma: pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia.
    • NSCLC: pyrexia, fatigue, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage, cough, and dyspnea.
    • Adult patients with solid tumors: pyrexia, fatigue, nausea, rash, chills, headache, hemorrhage, cough, vomiting, constipation, diarrhea, myalgia, arthralgia, and edema.
    • Pediatric patients with solid tumors: pyrexia, rash, vomiting, fatigue, dry skin, cough, diarrhea, dermatitis acneiform, headache, abdominal pain, nausea, hemorrhage, constipation, and paronychia.
    • Pediatric patients with LGG: pyrexia, rash, headache, vomiting, musculoskeletal pain, fatigue, diarrhea, dry skin, nausea, hemorrhage, abdominal pain and dermatitis acneiform.

Development timeline for Mekinist

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

Further information

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