Amgen announced that the Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) to include new evidence regarding the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

The accelerated approval is based on results from the Phase 1/2 ‘205, an open-label, multicenter, single-arm trial (n=93) that studied the efficacy and safety of Blincyto in pediatric patients with relapsed or refractory B-cell precursor ALL (second or later bone marrow relapse, any marrow relapse post-allogeneic hematopoietic stem cell transplantation, or refractory to other treatments and had >25% blasts in bone marrow). The treatment phase has been completed and patients are now being monitored for long-term efficacy.

Blincyto, a bispecific CD19-directed CD3 T cell engager (BiTE) antibody, is indicated for the treatment of Ph- relapsed or refractory B-cell precursor ALL. It binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. 

Blincyto has been granted breakthrough therapy, priority review, and orphan drug designations by the FDA. Continued approval may be contingent upon verification of clinical benefit in subsequent trials. 

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