Blinatumomab BLA to be Reviewed for Acute Lymphoblastic Leukemia
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.
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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