Amgen Submits BLA for Blinatumomab

Amgen has submitted  a biologics license application (BLA) to the US Food and Drug Administration (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.

BiTE antibody constructs represent an 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. The FDA states that breakthrough therapy designation, which is intended to expedite review of drugs for serious or life-threatening conditions, requires preliminary clinical evidence that demonstrates the drug may have substantial improvement over available therapies on at least one clinically significant endpoint.

BiTE antibody constructs are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.

Source: Amgen

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