First Immunotherapy for High Risk Neuroblastoma approved for use in the EU
EU regulators have issued approval for the first immunotherapy for high-risk neuroblastoma, which will offer a new treatment option to thousands of children affected by the rare and devastating form of cancer.
EUSA Pharma’s dinutuximab beta is a monoclonal chimeric antibody developed to target a specific antigen (GD2) on neuroblastoma cells, now indicated to treat the condition in children aged 12 months and above.
According to EU regulators, the drug offers an improvement in the survival of patients when compared with historical controls, while the common side effects were found to be pyrexia, pain and allergic reactions.
Each year around 1,200 children are diagnosed with neuroblastoma in the EU, a cancer that occurs from neural crest cells, which are involved in the foetal development of the nervous system and other tissues. Almost half of children are diagnosed at an advanced stage of their disease and are considered ‘high-risk’ with a poor prognosis.
According to EUSA, 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.
Approval of the drug allows the firm to now make it available for hospital use across Europe, improving access for thousands of children and their families to this new treatment, with proven improved survival rates, noted Steve Richards, chief executive of the neuroblastoma charity Solving Kids’ Cancer Europe.
“The next challenge will be for EUSA Pharma to engage with relevant access bodies throughout Europe, including NICE in the UK, to ensure timely review through the new drugs processes and secure access to this medicine for patients. The young innocent victims of this cruel and devastating disease deserve nothing less.”
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.