Amgen (NASDAQ:AMGN) today 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 1/2 ‘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.
“Historically, children with relapsed or refractory ALL have had limited pharmacologic options beyond chemotherapy, resulting in poor outcomes,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “This approval for BLINCYTO provides physicians across Europe with an important new immunotherapy option for these young, heavily pretreated patients, delivering on Amgen’s commitment to making a difference in the lives of cancer patients.”
ALL is a rapidly progressing cancer of the blood and bone marrow that occurs in both adults and children.1,2 In Europe, an estimated 5,000 children are diagnosed with ALL each year.3
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).
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