EMA Highlights: Green light for rare cancer treatments

by Gary Finnegan: Survival rates in young patients with high-risk neuroblastoma can be improved by Unituxin (dinutuximab), a new treatment approved by the European Medicines Agency (EMA).

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, according to the EMA’s Committee for Human Medicinal Products for Human Use (CHMP).
In a separate decision, the EMA also recommended extending the use of Imbruvica (ibrutinib) to include the treatment of patients with Waldenstrӧm’s macroglobulinaemia, a rare blood cell cancer. Imbruvica is the first medicine that is recommended for this disease.
The medicine is indicated for adults who have received at least one prior therapy or as a first line treatment for patients unsuitable for chemo-immunotherapy.
Imbruvica was first authorised in the European Union in October 2014 for the treatment of two other types of blood cancer: chronic lymphocytic leukaemia and mantle cell lymphoma.