The US Food and Drug Administration (FDA) has approved Amgen’s supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) to include new data that supports the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-), relapsed or refractory, B-cell, precursor acute lymphoblastic leukaemia (ALL).
The continued approval is expected to be contingent upon verification of clinical benefit in subsequent trials.
The approval is based on results from the Phase I/II '205, an open-label, multicentre, single-arm trial, which evaluated the safety of Blincyto in 93 pediatric patients.
The bispecific CD19-directed CD3 T-cell engager (BiTE) antibody construct Blincyto 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, and orphan drug designations by the FDA, and has now been approved in the US for the treatment of Ph- relapsed or refractory, B-cell precursor ALL.
Blincyto was granted conditional marketing authorisation in November last year in the European Union (EU) for the treatment of adults with Ph- relapsed or refractory, B-cell precursor ALL.
It is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.
Blincyto is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump, which should be programmable, lockable and non-elastomeric, as well as have an alarm.