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European Commission approves EUSA Pharma’s dinutuximab beta for neuroblastoma

Wednesday, May 10, 2017

EUSA Pharma (EUSA), a specialty pharmaceutical company with a focus on oncology and oncology supportive care, has announced that the European Commission has approved Dinutuximab beta for the treatment of patients with high-risk neuroblastoma. Dinutuximab beta is the only anti-GD2 monoclonal antibody approved in the European Union (EU). EUSA Pharma will begin commercializing Dinutuximab beta across the EU immediately.

Dinutuximab beta, originally developed by the Vienna-based biotech company Apeiron Biologics, was previously available in Europe under a managed access program, and following the positive CHMP opinion issued in March 2017 was granted expedited EU approval. Dinutuximab beta forms a core element of the treatment guidelines for high-risk neuroblastoma. The marketing authorization is based on data developed from multiple clinical trials conducted across Europe that included over 1,000 patients receiving Dinutuximab beta.

Lee Morley, EUSA Pharma’s chief executive officer, said, “We are delighted with this expedited EU approval for Dinutuximab beta as it provides an important new therapeutic option for children with high-risk neuroblastoma who currently have limited treatment choices. Neuroblastoma is a devastating disease that is responsible for up to 10% of childhood tumors, and EUSA is working hard to bring this life-saving therapy to children around the world. As part of this mission we plan to launch Dinutuximab beta immediately across the EU with our own team. In parallel we will file Dinutuximab beta with the FDA for approval in the U.S. as well as work with selected partners in other territories to secure access to Dinutuximab beta for patients worldwide.” 

Neuroblastoma is an orphan oncology condition with significant unmet medical need. It accounts for up to 10% of childhood tumors and affects approximately 1,200 children in Europe each year. Dinutuximab beta has been used extensively across Europe under a managed access scheme and is included in a number of treatment protocols for high-risk neuroblastoma.

Dinutuximab beta is an anti-GD2 monoclonal antibody that significantly improves event-free and overall survival in children with high- risk neuroblastoma, with a favorable safety profile compared with other immunotherapies. Dinutuximab beta forms an important part of treatment regimens for high-risk neuroblastoma and its novel features offer the potential for further development to expand its current role. Dinutuximab beta has Orphan Drug designation in the U.S., and EUSA plans to file the product for approval in the U.S. in 2017.

Dinutuximab beta is approved in Europe for use in children aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory neuroblastoma, with or without residual disease. In patients with previous relapsed / refractory disease and in patients who have not achieved a complete response after first line therapy, Dinutuximab beta should be combined with interleukin-2 (IL-2). Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilized by other suitable measures.

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