Amgen announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for blinatumomab, an investigational bispecific T cell engager (BiTE) antibody construct for the treatment of adults with Philadelphia-negative (PH-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

The BLA submission includes data from a Phase 2 trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which met its primary endpoint.

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Blinatumomab has previously received Orphan Drug designation, Breakthrough Therapy and Priority review designation from the FDA for the treatment of ALL.

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