Mekinist (trametinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Novartis Europharm Limited. Mekinist (trametinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf. Revised May 2026. Accessed August 2, 2026.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. 4
Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection. 2
Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation. 2
Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refactory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations Biomarkers Cancer types Therapies
EMA (2) BRAF p.V600E Melanoma Dabrafenib, Trametinib
EMA (2) BRAF p.V600K Melanoma Dabrafenib, Trametinib
EMA (1) BRAF p.V600E Non-Small Cell Lung Cancer Dabrafenib, Trametinib
EMA (1) BRAF p.V600E Melanoma Trametinib
EMA (1) BRAF p.V600K Melanoma Trametinib
EMA (1) BRAF p.V600K Non-Small Cell Lung Cancer Dabrafenib, Trametinib
EMA (1) BRAF p.V600E Differentiated Thyroid Gland Carcinoma Dabrafenib, Trametinib