
Amgen’s leukaemia treatment given FDA thumbs up for use in paediatric patients
pharmafile | September 2, 2016 | News story | Medical Communications, Sales and Marketing | Amgen, FDA, blincyto, leukaemia
Amgen has announced that the FDA has approved the supplemental Biologics License Application for Blincyto (blinatumomab) in the treatment of paediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
The decision is based on results from the drug’s Phase I/II trial and is approved under accelerated approval, with continued approval possibly contingent on its successes in further trials. The open-label, multicentre, single-arm study examined the safety and efficacy of Blincyto in 93 paediatric patients with relapsed or refractory B-cell precursor ALL (second or later bone marrow relapse, any marrow relapse after allogeneic haematopoietic stem cell transplantation [alloHSCT], or refractory to other treatments and had more than 25% blasts in bone marrow).
Blincyto 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.
The drug was granted breakthrough therapy, priority review and orphan drug designations by the FDA and in November 2015 was granted conditional marketing authorisation in the EU.
Matt Fellows
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