What is Mekinist - trametinib 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 to other parts of the body or cannot be removed by surgery. Mekinist is only intended for patients in whom melanoma cells have been analyzed and have shown a particular mutation (variation) in genes called "BRAF V600". Mekinist contains the active substance trametinib .
How is Mekinist - trametinib used?
Treatment with Mekinist should be started and supervised by a doctor experienced in the use of anticancer medicines. The medicine can only be obtained with a prescription. Mekinist is available as tablets (0.5 mg, 1 mg and 2 mg). It is given at a recommended dose of 2 mg once a day, taken at the same time each day. It must be taken without food, at least 1 hour before or 2 hours after the meal. It may be necessary to suspend or stop treatment, or reduce the dose, if the patient experiences some side effects, such as a severe rash. For more information, see the summary of product characteristics (included with EPAR).
How does Mekinist - trametinib work?
In melanomas with BRAF V600 mutation, an abnormal form of the BRAF protein is present, which activates another protein called MEK, involved in the stimulation of cell division. This promotes the development of the tumor, allowing the uncontrolled division of the cells. The active ingredient contained in Mekinist, trametinib, acts by blocking the MEK directly and preventing its activation by the BRAF, thus slowing down the growth and spread of the tumor. Mekinist is only given to patients whose melanoma is caused by a BRAF V600 mutation.
What benefit has Mekinist - trametinib shown during the studies?
Mekinist was 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 to the anticancer medicines dacarbazine or paclitaxel and the main measure of effectiveness was the survival of the patients until the 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 4.8 months without their disease getting worse, compared with 1.5 months for patients treated with dacarbazine or paclitaxel . Mekinist has also been studied in combination with the drug dabrafenib, but studies have not convincingly demonstrated the superiority of the combination compared to dabrafenib monotherapy: in the main combination study, mean progression-free survival was 9.3 months in patients treated with the combination, compared to 8.8 months in patients taking dabrafenib alone. In a further study, Mekinist demonstrated no benefit when it was given to patients who had not responded to previous treatment with another medicine called a BRAF inhibitor.
What is the risk associated with Mekinist - trametinib?
The most common side effects with Mekinist (which may affect more than 1 in 5 people) are rash, diarrhea, fatigue, peripheral edema (swelling, especially of the ankles and feet), nausea and acneiform dermatitis (inflammation of the skin). For the full list of all side effects reported with Mekinist and its limitations, see the package leaflet.
Why has Mekinist - trametinib been 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, used on its own, had shown a clinically relevant benefit in patients whose melanoma had a BRAF V600 mutation, compared to dacarbazine or paclitaxel. However, the CHMP was not convinced that Mekinist produced a benefit when used in combination with the drug dabrafenib, or in patients who had not responded to previous treatment with a BRAF inhibitor, and could not therefore recommend this use based on currently available data . In terms of safety, undesirable effects were considered acceptable and manageable with appropriate measures.
What measures are being taken to ensure the safe and effective use of Mekinist - trametinib?
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 is available in the summary of the risk management plan.
Other information on Mekinist - trametinib
On 30 June 2014, the European Commission issued a marketing authorization for Mekinist, valid throughout the European Union. For more information about treatment with Mekinist, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 06-2014.
