The Food and Drug Association has granted accelerated approval of blinatumomab for pediatric patients with Philadelphia chromosome–negative (Ph–) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Marketed by Thousand Oaks, California–based Amgen, and delivered via continuous intravenous infusion, blinatumomab (Blincyto) is a bispecific CD19-directed CD3 T cell engager 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. According to a press release from Amgen issued Sept. 1, its approval was based on results from the Phase 1/2 ’205, an open-label, multicenter, single-arm trial, which evaluated the efficacy and safety of blinatumomab in 93 pediatric patients with relapsed or refractory B-cell precursor ALL. Treatment in study ’205 has been completed and subjects are being monitored for long-term efficacy.
According to approved label information, cytokine release syndrome and neurological toxicities have occurred in patients receiving blinatumomab. Full prescribing information can be found at http://www.blincyto.com .
