Amgen files BLA for BiTE immunotherapy blinatumomab

22 September 2014

USA-based Amgen (Nasdaq: AMGN), the world’s largest independent biotech firm, has submitted a Biologics License Application (BLA) to the US Food and Drug Administration 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. Blinatumomab came into the Amgen pipeline along with its $1.26 billion acquisition of Germany’s Micromet.

Blinatumomab has breakthrough and orphan status

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