Mekinist

trametinib

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This is a summary of the European public assessment report (EPAR) for Mekinist. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Mekinist.

For practical information about using Mekinist, patients should read the package leaflet or contact their doctor or pharmacist.

What is Mekinist and what is it used for?

Mekinist is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread or cannot be surgically removed. It is used on its own or combination with another cancer medicine, dabrafenib.

Mekinist is only for patients whose melanoma cells have been tested and shown to have a specific genetic mutation (change) in their genes called 'BRAF V600'.

Mekinist contains the active substance trametinib.

How is Mekinist used?

Treatment with Mekinist must be started and supervised by a doctor experienced in the use of cancer medicines. The medicine can only be obtained with a prescription.

Mekinist is available as tablets (0.5 mg, 1 mg and 2 mg). The dose of Mekinist either used alone or in combination with dabrafenib is 2 mg once a day, at a similar time every day.

Mekinist should be taken without food, at least 1 hour before or 2 hours after a meal. Treatment may need to be interrupted or stopped, or the dose reduced, if the patient experiences certain side effects. For further information, see the summary of product characteristics (also part of the EPAR).

How does Mekinist work?

In melanoma with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division. This encourages cancer to develop by allowing uncontrolled division of cells. The active substance in Mekinist, trametinib, works by blocking MEK directly and by preventing its activation by BRAF thereby slowing down the growth and spread of the cancer. Mekinist is only given to patients whose melanoma is caused by the BRAF V600 mutation.

What benefits of Mekinist have been shown in studies?

Mekinist has been studied in one main study involving 322 patients with melanoma that had spread to other parts of the body or could not be surgically removed, and whose melanoma had the BRAF V600 mutation. Mekinist alone was compared with the cancer medicines dacarbazine or paclitaxel, and the main measure of effectiveness was how long patients lived until their disease got worse (progression-free survival). In this study Mekinist was more effective than dacarbazine or paclitaxel in controlling the disease: patients taking Mekinist lived on average for 4.8 months without their disease getting worse, compared with 1.5 months for patients given dacarbazine or paclitaxel.

In an additional study Mekinist did not show any benefit when given to patients who did not respond to previous treatment with another medicine called a BRAF inhibitor.

In one of two studies of Mekinist in combination with dabrafenib, 423 patients were given either the combination or dabrafenib alone. The result was that patients given the combination lived for 11 months without their disease worsening, while those given dabrafenib alone lived for 8.8 months without their disease worsening. In a second study involving 704 patients, Mekinist with dabrafenib was compared with another medicine for melanoma, vemurafenib. Patients given the combination lived longer on average, 25.6 months versus 18 months with vemurafenib.

What are the risks associated with Mekinist?

The most common side effects with Mekinist (which may affect more than 1 in 5 people) are rash, diarrhoea, fatigue, peripheral oedema (swelling, especially of ankles and feet), nausea and dermatitis acneiform (acne-like inflammation of the skin).

When Mekinist is taken in combination with dabrafenib the most common side effects (seen more than 1 in 5 people) are fever, tiredness, nausea, headache, chills, diarrhea, rash, joint pain, high blood pressure, vomiting and cough.

For the full list of all side effects and restrictions with Mekinist, see the package leaflet.

Why is Mekinist approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Mekinist’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee considered that Mekinist when used alone or in combination with dabrafenib had shown a clinically relevant benefit in patients whose melanoma had a BRAF V600 mutation. In terms of safety, the side effects were considered acceptable and manageable with appropriate measures.

What measures are being taken to ensure the safe and effective use of Mekinist?

A risk management plan has been developed to ensure that Mekinist is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Mekinist, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Mekinist

The European Commission granted a marketing authorisation valid throughout the European Union for Mekinist on 30 June 2014.

For more information about treatment with Mekinist, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Mekinist : EPAR - Summary for the public BG = bălgarski 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public ES = español 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public CS = čeština 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public DA = dansk 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public DE = Deutsch 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public ET = eesti keel 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public EL = elliniká 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public EN = English 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public FR = français 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public IT = italiano 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public LV = latviešu valoda 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public LT = lietuvių kalba 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public HU = magyar 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public MT = Malti 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public NL = Nederlands 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public PL = polski 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public PT = português 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public RO = română 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public SK = slovenčina 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public SL = slovenščina 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public FI = suomi 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public SV = svenska 2014-07-09 2015-11-04
Mekinist : EPAR - Summary for the public HR = Hrvatski 2014-07-09 2015-11-04
Name Language First published Last updated
Mekinist : EPAR - Risk-management-plan summary (English only) 2014-07-09  

This EPAR was last updated on 28/09/2016 .

Authorisation details

Product details

Product details for Mekinist
NameMekinist
Agency product numberEMEA/H/C/002643
Active substance

trametinib

International non-proprietary name (INN) or common name

trametinib

Therapeutic area Melanoma
Anatomical therapeutic chemical (ATC) code L01XE25
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Mekinist
Marketing-authorisation holder

Novartis Europharm Limited

Revision8
Date of issue of marketing authorisation valid throughout the European Union30/06/2014

Contact address:

Novartis Europharm Limited
Frimley Business Park
Camberley GU16 7SR 
United Kingdom

Product information

Product information

16/08/2016  Mekinist -EMEA/H/C/002643 -PSUSA/10262/201511

Name Language First published Last updated
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - Product Information EN = English 2014-07-09 2016-09-28

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28
Mekinist : EPAR - All Authorised presentations EN = English 2014-07-09 2016-09-28

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Mekinist : EPAR - Public assessment report EN = English 2014-07-09  
CHMP summary of positive opinion for Mekinist EN = English 2014-04-25