ch14.18/CHO dinutuximab beta Qarziba®
Antibody-based treatment for children with neuroblastoma. APN311 is a monoclonal chimeric antibody produced in CHO cells targeting the GD2 antigen which is overexpressed on neuroblastoma cells. It has been investigated in several late-stage academic clinical trials against neuroblastoma (a rare childhood cancer), with more than 1.000 patients having received treatment to date. Based on a major collaborative effort together with the academic institutions SIOPEN, CCRI, Pediatric Oncology at the University Medicine Greifswald and others, in May 2017 Apeiron has received marketing authorization for immunotherapy of neuroblastoma in the EU.
For the European public assessment report (EPAR) see http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003918/human_med_002104.jsp&mid=wc0b01ac 058001d124.
In September 2016, the product (present trade name Qarziba®) has been licensed to EUSA Pharma Ltd for worldwide development, distribution, marketing and sales as well as for further product launches.