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. Mekinist is used on its own or combination with another cancer medicine, dabrafenib;
  • advanced non-small cell lung cancer. It is used in combination with dabrafenib.

Mekinist is only for patients whose cancer cells 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, 1 and 2 mg). The dose of Mekinist either used alone or in combination with dabrafenib is 2 mg once a day, taken at around the same time every day.

Mekinist is taken at least 1 hour before or 2 hours after a meal. Treatment may need to be interrupted or stopped, or the dose reduced, if certain side effects occur. Mekinist can be continued for as long as the patient benefits from it. For further information, see the summary of product characteristics (also part of the EPAR).

How does Mekinist work?

In melanoma and non-small cell lung cancer 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 cancers 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 cancer is caused by the BRAF V600 mutation.

What benefits of Mekinist have been shown in studies?

Melanoma

Mekinist has been shown to be more effective than the cancer medicines dacarbazine or paclitaxel at controlling melanoma that had spread to other parts of the body or could not be surgically removed, in patients whose melanoma had the BRAF V600 mutation. This was based on a main study involving 322 patients who received either Mekinist or the comparator medicine and which measured how long patients lived until their disease got worse (progression-free survival). 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 cancer medicine that blocked BRAF.

Two additional studies looked at using the combination of Mekinist and dabrafenib. In one study, 423 patients were given either the combination or dabrafenib alone. 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.

Non-small cell lung cancer

In one main study, 171 patients with BRAF V600 mutated non-small cell lung cancer either received dabrafenib combined with Mekinist or dabrafenib alone. The main measure of effectiveness was the percentage of patients who responded completely or partially to treatment. Response to treatment was assessed using body scans and patients’ clinical data. The use of Mekinist and dabrafenib led to a response in over 60% of the patients, compared with 23% of patients using dabrafenib alone.

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, tiredness, 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, diarrhoea, 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 with melanoma or non-small cell lung cancer who 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?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mekinist have been included in the summary of product characteristics and the package leaflet.

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 2017-06-15
Mekinist : EPAR - Summary for the public ES = español 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public CS = čeština 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public DA = dansk 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public DE = Deutsch 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public ET = eesti keel 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public EL = elliniká 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public EN = English 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public FR = français 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public IT = italiano 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public LV = latviešu valoda 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public LT = lietuvių kalba 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public HU = magyar 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public MT = Malti 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public NL = Nederlands 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public PL = polski 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public PT = português 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public RO = română 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public SK = slovenčina 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public SL = slovenščina 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public FI = suomi 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public SV = svenska 2014-07-09 2017-06-15
Mekinist : EPAR - Summary for the public HR = Hrvatski 2014-07-09 2017-06-15
Name Language First published Last updated
Mekinist : EPAR - Risk-management-plan summary (English only) 2014-07-09  

This EPAR was last updated on 15/06/2017 .

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

Revision9
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

29/03/2017  Mekinist -EMEA/H/C/002643 -WS/0996

Name Language First published Last updated
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06
Mekinist : EPAR - Product Information EN = English 2014-07-09 2017-06-06

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

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.

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

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