FDA Approves Amgen Drug for Acute Lymphoblastic Leukemia

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Amgen's bispecific T-cell engager (BiTE) antibody constructs help the body fight malignant cancer cells.

FDA approved Blincyto (blinatumomab) on Dec. 3, 2014 for the treatment of Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), which is said to be a fairly uncommon form of ALL. There are four known cytogenetic subtypes of precursor B-cell acute lymphoblastic leukemia/lymphoma.

B-cell ALL is characterized by the overproduction of immature white blood cells in the bone marrow. According to a FDA press release, Blincyto is the first approved drug that reprograms the body’s T cells to find and kill leukemia cells. Amgen acquired Blincyto through the purchase of Germany-based biotech firm Micromet for $1.16 billion in 2012.

“Immunotherapies, especially Blincyto with its unique mechanism of action, are particularly promising with patients with leukemia,” said Richard Padzur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, in a conferred a 90% remission rate in children and adults with relapsed, refractory ALL.


Both Blincyto and the investigational therapy from Novartis look for cancer cells that express specific proteins, called CD19, which are found on the surface of most B-cell lymphoblasts.