Mekinist is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) in their genes called 'BRAF V600'. It is used for the treatment of:
- melanoma (a skin cancer) that has spread or cannot be removed surgically. Mekinist is used on its own or in combination with another cancer medicine, dabrafenib;
- advanced (stage III) melanoma after surgery for it. Mekinist is used in combination with dabrafenib;
- advanced non-small cell lung cancer. It is used in combination with dabrafenib.
Mekinist contains the active substance trametinib.
Mekinist : EPAR - Medicine overview (PDF/83.5 KB)
First published: 09/07/2014
Last updated: 07/09/2018
Mekinist : EPAR - Risk-management-plan summary (PDF/85.07 KB)
First published: 09/07/2014
Last updated: 05/05/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
24/02/2023 Mekinist - EMEA/H/C/002643 - IAIN/0058
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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 (see sections 4.4 and 5.1).
Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1).
Adjuvant treatment of melanoma
Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
Non-small cell lung cancer (NSCLC)
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 201724/02/2017
European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 201410/07/2014