Yervoy - ipilimumab

What is Yervoy - ipilimumab?

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

What is Yervoy - ipilimumab used for?

Yervoy is indicated for the treatment of advanced melanoma (a type of skin cancer associated with cells called melanocytes). It is used in patients who have previously undergone therapy but has not worked or is no longer effective.

The medicine can only be obtained with a prescription.

How is Yervoy - ipilimumab used?

Treatment with Yervoy must be started and followed by medical specialists with experience in cancer treatment.

The doctor must perform blood tests to check the patient's liver and thyroid function before starting treatment and regularly during the same.

Yervoy is given as a 90-minute intravenous infusion. The patient receives a total of four doses, at intervals of three weeks between one dose and another. The recommended dose for each infusion is 3 mg / kg body weight.

How does Yervoy - ipilimumab work?

The active substance in Yervoy, ipilimumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize a specific structure (called an antigen) present in some cells of the body and bind to it.

Ipilimumab was created to bind to a protein called CTLA-4, which is present on the surface of T cells (a type of white blood cell), and block its activity. The CTLA-4 protein inhibits T cell activity. Ipilimumab, by blocking CTLA-4, allows the activation and diffusion of T cells, which infiltrate tumor cells left in the body after previous therapy and destroy them.

What studies have been carried out on Yervoy - ipilimumab?

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

A main study was conducted involving 676 patients who were given Yervoy, an experimental medicine called "gp100" or a combination of Yervoy and gp100. All patients had previously been treated for advanced melanoma. The main measure of effectiveness was overall survival (the duration of their life).

What benefit has Yervoy - ipilimumab shown during the studies?

Yervoy has been shown to improve overall survival. Patients on Yervoy or in combination therapy survived for about 10 months, compared to 6 months in the case of gp100 monotherapy.

What is the risk associated with Yervoy - ipilimumab?

Yervoy is usually associated with side effects due to excessive activity of the immune system, including severe reactions and inflammation. Most side effects cease with adequate therapy or with discontinuation of Yervoy treatment. The most common single side effects, seen in more than 10% of patients, are diarrhea, skin erythema, itching, feeling tired, nausea, vomiting, loss of appetite and abdominal pain. 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.

Why has Yervoy - ipilimumab been approved?

The CHMP noted that Yervoy has been shown to improve survival in a situation where overall survival rates are low. Regarding the side effects of the medicine, the most common were mild to moderate. The CHMP therefore decided that Yervoy's benefits are greater than its risks and recommended that it be given marketing authorization.

What measures are being taken to ensure the safe use of Yervoy - ipilimumab?

The company that makes Yervoy must ensure that all health professionals who could prescribe the medicine and all patients receive a leaflet with information on the safety of the medicine, among other things with regard to the undesirable effects related to the hyperactivity of the immune system. Patients will also receive an alert card from their doctor with a summary of essential information on the safety of the medicine.