FDA approves new indication for Blincyto

15 June 2024
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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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