FDA Grants New Indication for Blinatumomab

The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for blinatumomab (BLINCYTO®) to include new findings supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Blinatumomab 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.

The approval is based on results from the Phase I/II ‘205, an open-label, multicenter, single-arm trial that evaluated the efficacy and safety of BLINCYTO in pediatric patients with this leukemia.

Th study evaluated 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.

Continued approval may be contingent upon verification of clinical benefit in subsequent trials. —Amanda Del Signore

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