FDA OKs Pediatric Use for Amgen’s Leukemia Drug
Amgen has received approval from the US Food and Drug Administration (FDA) for a supplemental biologics license application for Blincyto (blinatumomab) to include new data for treating pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may be contingent upon verification of clinical benefit in subsequent trials.
Blincyto is a bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. It was granted breakthrough therapy, priority review, and orphan drug designations by the FDA and is now approved in the US for the treatment of Ph- relapsed or refractory B-cell precursor ALL.
In November 2015, Blincyto was granted conditional marketing authorization in the European Union for the treatment of adults with Ph- relapsed or refractory B-cell precursor ALL.