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CANCER DIGEST – July 8, 2014 – The FDA granted breakthrough therapy status to blinatumomab for the most common form of acute lymphoblastic leukemia (ALL). The cancer results from too many immature white blood cells in the blood and bone marrow. To get breakthrough designation, a drug must show preliminary clinical evidence indicating the drug may demonstrate substantial improvement over existing therapies. A total of 82 of 189 (43 percent) patients treated with blinatumomab achieved a complete remission or a partial hematological recovery. The results were presented at the 2014 ASCO Annual Meeting in June. Blinatumomab is an engineered antibody that directs T-cells in the immune system to attack cells that produce certain molecules found on the surface of the abnormal ALL white blood cells. Sean E. Harper, MD, executive vice president, Research and Development at Amgen, which makes the drug, said in a press release that the company is currently recruiting for a large clinical trial that will compare blinatumomab to standard chemotherapy, and plans to enroll 400 patients over the next two to three years.
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