The European Commission has approved dinutuximab beta for high risk neuroblastoma patients over the age of 12 months, making it the only approved immunotherapy in Europe for this group of patients.
Affecting around 1200 children every year in Europe, neuroblastoma is the second most common solid tumor in childhood and predominately affects children younger than 5 years of age. The novel immunotherapy from EUSA Pharma (London, UK) approved by the European Commission, dinutuximab beta, is a monoclonal chimeric antibody developed to specifically target the GD2 antigen on neuroblastoma cells. The immunotherapy has been extensively investigated in clinical trials, with over 1000 patients having received the treatment to date.
Steve Richards, CEO of the neuroblastoma charity Solving Kids’ Cancer Europe (London, UK) commented: “In the absence of any other targeted immunotherapy for children with high-risk neuroblastoma, the European regulatory body that approves medicines to be marketed in Europe, expedited the review of dinutuximab beta. Today’s approval means that EUSA Pharma who manufactures dinutuximab beta is able to make it available for use by hospitals across Europe, improving access for thousands of children and their families to this new treatment, with proven improved survival rates.”
Dinutuximab beta will be utilized in 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.
Juliet Gray from the University of Southampton (UK) commented on the clinical significance of the approval: “Today’s announcement is a leap forward for the children and families affected by neuroblastoma, particularly those who have keenly followed the positive clinical trial results for dinutuximab beta and long anticipated its approval in Europe. As a clinician working in a highly specialised disease area with limited treatment options, I greatly welcome the availability of this targeted immunotherapy treatment that offers improved results for high-risk neuroblastoma patients used alone or in combination with existing therapies.”
The immunotherapy currently holds orphan drug status in the USA and European Union, and in 2017, EUSA Pharma plans to file dinutuximab beta for approval in the USA.