Mekinist

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trametinib

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 27/02/2019

Authorisation details

Product details
Name
Mekinist
Agency product number
EMEA/H/C/002643
Active substance
trametinib
International non-proprietary name (INN) or common name
trametinib
Therapeutic area (MeSH)
Melanoma
Anatomical therapeutic chemical (ATC) code
L01XE25
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
30/06/2014
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

14/02/2019 Mekinist - EMEA/H/C/002643 - R/0029

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Melanoma

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.

Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy.

Adjuvant treatment of melanoma

Dabrafenib in combination with trametinib 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.

Assessment history

Changes since initial authorisation of medicine

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