Blinatumomab Considered for Supplemental Use in Pediatrics
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.Wolters Kluwer Health, Inc. All rights reserved.