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Blinatumomab Considered for Supplemental Use in Pediatrics

doi: 10.1097/01.COT.0000503440.62011.4b
FDA Updates
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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.
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