European Commission approves Blincyto for pediatric patients aged one year or older with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia .- Amgen.

Amgen announced that the European Commission (EC) has approved an expanded indication for Blincyto (blinatumomab) as monotherapy for the treatment of pediatric patients aged one year or older with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL), which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.

The approval is based on results from the Phase 1/II '205 study, an open-label, multicenter, single-arm trial which evaluated the efficacy and safety of Blincyto in pediatric patients with relapsed or refractory B-cell precursor ALL. Blincyto is the first-and-only bispecific T cell engager (BiTE) immunotherapy construct approved globally. It is also the first immunotherapy from Amgen's BiTE platform, an innovative approach that helps the body's immune system target cancer cells. Approval via the centralized procedure grants a marketing authorization from the EC, which is valid in all European Union (EU) and European Economic Area (EEA)- European Free Trade Association (EFTA) states ( Norway , Iceland and Liechtenstein ).