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 intended only for patients in whom melanoma cells have been analyzed and showed a particular mutation (variation) in the genes called “BRAF V600”. Mekinist contains the active substance trametinib.
How is Mekinist used - trametinib?
Treatment with Mekinist should be initiated 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 administered. at a recommended dose of 2 mg once daily, to be taken at the same time each day. It should be taken without food, at least 1 hour before or 2 hours after a meal. It may be necessary to interrupt or stop treatment, or reduce the dose , if the patient experiences certain side effects, such as severe rash For more information, see the Summary of Product Characteristics (included in the EPAR).
How does Mekinist - trametinib work?
In melanomas with the BRAF V600 mutation, there is an abnormal form of the BRAF protein, which activates another protein called MEK, which is involved in stimulating cell division. This promotes tumor development, allowing uncontrolled cell division. The active ingredient contained in Mekinist, trametinib works by blocking the MEK directly and preventing it from being activated by BRAF, thus slowing 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 that could not be removed by surgery and whose melanoma had the BRAF V600 mutation. Mekinist alone was compared with the anticancer medicines dacarbazine or paclitaxel and the main measure of effectiveness was how long the patients survived 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 an average of 4.8 months without their disease getting worse, compared with 1.5 months for patients taking dacarbazine or paclitaxel. . Mekinist was also studied in combination with the medicinal product dabrafenib, but the studies did not convincingly demonstrate the superiority of the combination over dabrafenib alone: in the pivotal combination study, the mean progression-free survival was 9.3 months in patients treated with the combination, compared with 8.8 months in patients taking dabrafenib alone. In a further study, Mekinist showed no benefit when 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 side effects reported with Mekinist and their 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 alone, demonstrated 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 would produce a benefit when used in combination with the medicinal product dabrafenib, or in patients who did not have responded to previous treatment with a BRAF inhibitor, and could therefore not recommend this use based on currently available data.In terms of safety, side 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 added to the summary of product characteristics and 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 about Mekinist - trametinib
On 30 June 2014, the European Commission issued a "Marketing Authorization" for Mekinist, valid throughout the European Union. For more information on Mekinist therapy, read the package leaflet (included with the EPAR) or consult your doctor or the pharmacist. Last update of this summary: 06-2014.
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