The European Commission granted accelerated approval for EUSA Pharma’s anti-GD2 monoclonal antibody dinutuxumab beta as a treatment for children aged over 12 months with high-risk neuroblastoma. The drug was originally developed by Austrian cancer immunotherapeutics firm Apeiron Biologics and has been available in Europe under a managed access program. U.K.-based EUSA acquired exclusive global commercialization rights to dinutuximab beta in October last year.
Approval of dinutuximab beta in Europe is based on data from multiple clinical trials including over 1000 patients. Lee Morley, EUSA Pharma CEO, said the firm will use its own teams to launch the drug across the EU immediately. “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. 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.”
EC clearance of dinutuximab beta covers use of the drug 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 in patients with a history of relapsed or refractory neuroblastoma, with or without residual disease. In patients with previous relapsed or 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).
EUSA Pharma was founded in 2015 to develop a pipeline of acquired and in-licensed pharmaceutical products. The firm currently markets or distributes Caphosol®, Collatamp®, Xenazine®, and Custodiol® in specified markets. EUSA’s development pipeline includes dinutuximab beta and the vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor tivozanib, which EUSA is developing under license from AVEO Pharma in Europe and other specified countries outside of North America. The firms submitted an MAA to the European Medicines Agency in March 2016 for tivozanib as first-line treatment for advanced renal cell carcinoma.