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Amgen’s Blincyto ( blinatumomab) gets full EU approval for Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Amgen has announced that the European Commission (EC) has granted a full marketing authorization for BLINCYTO (blinatumomab) based on the overall survival (OS) data from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (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.”

BLINCYTO is the first-and-only bispecific CD19-directed CD3 T cell engager (BiTE®) immunotherapy construct approved globally. It is also the first bispecific immunotherapy from Amgen’s BiTE® platform, an innovative approach that helps the body’s immune system target cancer cells.

ALL is a rare and rapidly progressing cancer of the blood and bone marrow. The incidence of adult ALL in European countries is generally between 0.6 to 0.9 per 100,000 persons per year. In adult ALL, approximately 75 percent is B-cell precursor ALL, of which 75-80 percent is Ph- and roughly half will be refractory to treatment or experience relapse. Thus, with a population projection of 416 million adults in the EU, it is estimated that the incidence of adult Ph- relapsed or refractory B-cell precursor ALL in the EU is approximately 900 patients per year.

BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE®) immunotherapy construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of effector T cells. BLINCYTO was granted breakthrough therapy and priority review designations by the FDA in 2014, and carries full approval in the U.S. for the treatment of relapsed or refractory B-cell precursor ALL in adults and children. In the U.S., BLINCYTO is also approved under accelerated approval for the treatment of adults and children with B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent. This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival (RFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

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