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Yervoy is approved to treat advanced melanoma


Yervoy is a medicine that contains the active substance ipilimumab. It is available as a concentrate that is made up into a solution for infusion (drip into a vein).

Yervoy is used to treat advanced melanoma (a type of skin cancer affecting cells called melanocytes). It is used in adults who have been previously treated, but for whom treatment has not worked or has stopped working.

The medicine can only be obtained with a prescription.

Treatment with Yervoy should be started and supervised by a specialist doctor experienced in treating cancer.

The doctor should carry out blood tests to check the patient’s liver and thyroid function before and regularly during treatment.

Yervoy is given as an infusion into a vein over 90 minutes. The patient receives four doses in total, with three weeks between each dose. The recommended dose for each infusion is 3 mg per kilogram body weight.

The active substance in Yervoy, ipilimumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.

Ipilimumab has been designed to attach to and block the activity of a protein called CTLA-4 that is found on the surface of T cells, a type of white blood cell. CTLA-4 inhibits the activity of T cells. Ipilimumab, by blocking CTLA-4, leads to the activation and spread of the T cells, which infiltrate and kill tumour cells that have remained in the body after previous treatment.

The effects of Yervoywere first tested in experimental models before being studied in humans.

One main study involving 676 patients was carried out in which the patients received treatment with Yervoy, treatment with an experimental medicine called ‘gp100’, or treatment with a combination of Yervoy and gp100. All patients had previously been treated for advanced melanoma. The main measure of effectiveness was overall survival (how long the patients lived).

Yervoy was shown to improve overall survival. Patients survived for around 10 months on treatment with Yervoy or the combination treatment, compared with 6 months on gp100 alone.

Yervoy is commonly associated with side effects resulting from excessive activity of the immune system, including severe reactions and inflammation. Most will resolve following appropriate treatment or on stopping Yervoy. The most common individual side effects, affecting more than 10% of patients, are diarrhoea, rash, pruritus (itching), fatigue (tiredness), nausea (feeling sick), vomiting, decrease appetite and abdominal pain (stomach ache). For the full list of all side effects reported with Yervoy, see the package leaflet.

Yervoy should not be used in people who may be hypersensitive (allergic) to ipilimumab or any of the other ingredients.

The CHMP noted that Yervoy has been shown to improve survival in a condition where overall survival rates are low. With regard to the medicine’s side effects, the most frequent were mild to moderate in severity. The CHMP therefore decided that Yervoy’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The company that makes Yervoy must ensure that all healthcare professionals expected to prescribe the medicine as well as patients are provided with a brochure with safety information on the medicine including the side effects related to the excessive activity of the immune system. Patients will also receive from their doctor an alert card summarising key safety information on the medicine.

The European Commission granted a marketing authorisation valid throughout the European Union for Yervoy on 13.07.2011.

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


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Source :

European Medicine Agency






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