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New indication approved by EMA for Yervoy (ipilimumab)

On 26 April 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Yervoy. The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.

The CHMP adopted a change to the existing indication as follows:

“Yervoy as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults, and adolescents 12 years of age and older.

Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression

Yervoy is a medicine that increases the activity of the immune system (the body’s natural defences) and is used to treat adults with advanced melanoma (a type of skin cancer affecting cells called melanocytes).

Yervoy contains the active substance ipilimumab.

The active substance in Yervoy, ipilimumab, is a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific target on cells in the body.

Ipilimumab acts on a type of white blood cells called T cells which form part of the immune system. It attaches to and blocks the activity of CTLA-4, a protein that controls the activity of T cells. By blocking CTLA-4, ipilimumab causes activation and increase of T cells, which enter into tumours and kill the tumour cells.

The European Medicines Agency noted that Yervoy improves 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 Agency therefore decided that Yervoy’s benefits are greater than its risks and recommended that it be given marketing authorisation. Despite longer survival with a dose of 10 mg per kg, the Agency recommended using Yervoy at a dose of 3 mg per kg because the dose of 10 mg per kg caused more side effects and worsened patients’ quality of life after the start of treatment.

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