The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma, a type of cancer that most often occurs in young children. Unituxin is to be used in children who have responded to an induction treatment with chemotherapy, followed by myeloablative therapy and autologous stem-cell transplantation.

Neuroblastoma is a rare cancer that forms from immature nerve cells. It is usually seen as a lump in the abdomen or around the spine and typically occurs in children under five years of age. In many cases it is present at birth, but is diagnosed only later when the cancer has already spread to other parts of the body and the child begins to show symptoms of the disease. Patients with neuroblastomas classed as ‘high risk’ have a lower survival rate than for other neuroblastomas, and Unituxin provides a much-needed treatment option to prolong survival in this group of patients.

Unituxin is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific structure (an antigen) called disialoganglioside (GD2), which is present in high amounts on the surface of neuroblastoma cells, but in lower amounts in normal cells. When the medicine attaches to the neuroblastoma cells, it marks them out as targets for the body’s immune system, which is then expected to attack the cancer cells and thereby reverse or slow down the progression of the disease.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/05/news_detail_002333.jsp&mid=WC0b01ac058004d5c1