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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.

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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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