The FDA has approved the supplemental Biologics License Application for blinatumomab (Blincyto) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval. The approval is based on results from the phase I/II study 205, an open-label, multicenter, single-arm trial, which evaluated the study efficacy and safety of blinatumomab in pediatric patients with relapsed or refractory B-cell precursor ALL.
Study 205 evaluated the safety and efficacy of blinatumomab in 93 pediatric patients with relapsed or refractory B-cell precursor ALL (second or later bone marrow relapse, any marrow relapse after allogeneic hematopoietic stem cell transplantation [alloHSCT], or refractory to other treatments and had >25% blasts in bone marrow). Treatment in this study has been completed and subjects are being monitored for long-term efficacy.
Blinatumomab 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.