Amgen announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for blinatumomab, a bispecific T cell engager (BiTE) antibody construct, for the treatment of Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
The submission included data from a Phase 2 trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which successfully met its primary endpoint.
BiTE antibody constructs assist the body’s immune system by targeting cancer cells. Blinatumomab, the first of the BiTE antibody constructs, has received both Orphan Drug designation and Breakthrough Therapy designation from the FDA for the treatment of ALL.
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