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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/670250/2015

EMEA/H/C/002643

EPAR summary for the public

Mekinist

trametinib

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).

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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 (progressionfree 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.

The full EPAR and risk management plan summary for Mekinist can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Mekinist, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2015.

Mekinist

EMA/670250/2015

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