FDA approves new indication for Blincyto
The US Food and Drug Administration (FDA) on Friday approved Blincyto (blinatumomab) for the treatment of an aggressive blood cancer.
Marketed by US biotech major Amgen (Nasdaq: AMGN), Blincyto is now authorized for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph-negative BCP ALL) in the consolidation phase of multiphase chemotherapy.
The approval marks the third indication for Blincyto, which is deemed a profit-driver for Amgen, and is based primarily on the Phase III E1910 clinical trial led by ECOG-ACRIN Cancer Research Group that studied patients with newly-diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment, which aims to deepen remission to achieve durable responses.
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