EU approves ch14.18/CHO, dinutuximab beta, as a treatment for high risk neuroblastoma in children. EUSA Pharma

EUSA Pharma announced that the European Commission (EC) has approved the antibody ch14.18/CHO, dinutuximab beta, for the treatment of high-risk neuroblastoma in patients aged 12 months and above. This announcement makes dinutixumab beta the only approved immunotherapy in Europe for high risk neuroblastoma and an important tool in the fight against the condition. Neuroblastoma, is the second most common solid tumour in childhood, following brain tumours and predominantly affects children under five years old. Every year in Europe, around 1,200 children are diagnosed with neuroblastoma, a rare cancer arising from neural crest cells, which are involved in the foetal development of the nervous system and other tissues.

Because neuroblastoma can spread very quickly, almost half of children are initially diagnosed at an advanced stage of their disease and are recognised as �high-risk� and with a poor prognosis. Approval of dinutuximab beta brings new hope to these �high-risk� children who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as those with history of relapsed or refractory neuroblastoma, with or without residual disease.

Comment: EUSA, which acquired exclusive global commercialisation rights to the drug from Apeiron Biologics in October last year, said it also expects to file the product for registration in the US and Japan in 2017.