Amgen ( AMGN) has won U.S. approval for a new type of immunotherapy to treat a relatively rare form of leukemia, according to an announcement made by the U.S. Food and Drug Administration.
The Amgen drug is blinatumomab, which will be sold under the brand name Blincyto. The drug is an antibody which works by steering a patient's killer T cells to recognize a protein known as CD19, expressed on the surface of leukemic B cells. The FDA approved Blincyto to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), a fast-growing form of leukemia in which the a patient's bone marrow becomes over-crowded with immature white blood cells known B-cell lymphoblasts.
The FDA previously granted Breakthrough Therapy Designation status to Blincyto. Wednesday's approval comes more than five months ahead of the expected May 19, 2015 approval decision date.
The pivotal clinical trial upon which Blincyto was approved enrolled 185 adults with B-cell ALL no longer responding to previous treatments. Following treatment with Blincyto, 32% of patients had a complete remission, meaning there was no evidence of the cancer in their body. The median duration of response was 6.7 months.
Amgen acquired Blincyto through the purchase of Micromet for $1.2 billion in 2012.