Amgen granted marketing authorization for BLINCYTO by European Commission
Amgen announced that the European Commission, or EC, has granted a full marketing authorization for BLINCYTO, or blinatumomab, based on the overall survival, or OS, data from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia, or ALL. "BLINCYTO is the first single agent immunotherapy to demonstrate superior overall survival benefit over standard of care," said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen. "For decades, overall survival has been the gold standard for assessing the efficacy of treatments for blood cancers. The near doubling of median overall survival versus standard of care seen in the TOWER study is groundbreaking and reinforces BLINCYTO as a highly effective ALL therapy, providing physicians with a much needed, efficacious treatment option, potentially offering patients the chance to live longer."