Amgen files BLA at FDA for blinatumomab for treatment of Acute Lymphoblastic Leukemia.
Amgen announced submission of a Biologics License Application (BLA) to the FDA seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. The BLA is for the treatment of adults with Philadelphia -negative (Ph-) relapsed/refractory B-precursor Acute Lymphoblastic Leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow. The submission includes data from a Phase II trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which successfully met its primary endpoint.
BiTE antibody constructs represent an innovative immunotherapy approach that helps the body's immune system target 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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