EMA issues positive opinion for EUSA Pharma's Dinutuximab beta to treat neuroblastoma


The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion in favour of marketing authorisation for EUSA Pharma’s antibody ch14.18/CHO, Dinutuximab beta, to treat high-risk neuroblastoma in Europe.

The antibody has been approved to treat children aged 12 months and above who have received induction chemotherapy earlier and achieved at least a partial response, as well as patients with a history of relapsed or refractory neuroblastoma. 

It should be combined with interleukin-2 (IL-2) in patients with a history of relapsed / refractory disease, and in patients who have not achieved a complete response after first line therapy. 

Neuroblastoma is the second most common solid tumour in childhood and predominantly affects children aged below five years.

University of Southampton Paediatric Oncology associate professor and consultant Dr Juliet Gray said: "Today's news is an important milestone for the neuroblastoma research and patient communities that have witnessed the positive outcomes for children treated by Dinutuximab beta in the clinical trials.

"I welcome this positive step towards a new, targeted immunotherapy that I can be confident offers improved results for this group in combination with existing therapies."

"As a clinician working with limited treatment options for those with high-risk neuroblastoma, I welcome this positive step towards a new, targeted immunotherapy that I can be confident offers improved results for this group in combination with existing therapies."

It was noted that any actively progressing disease should be stabilised by other suitable measures before treating relapsed neuroblastoma.

The latest approval means that children affected by this aggressive form of cancer now have improved access to the new Dinutuximab beta monoclonal antibody treatment.

Dinutuximab beta was initially established by Apeiron Biologics, and is currently used in Europe under a managed access programme as part of treatment regimens for high-risk neuroblastoma. EUSA holds exclusive global commercial rights to the antibody.

The antibody will be indicated for use in the 28 countries of the European Union upon approval.