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Cancer Therapy
U.S. FDA expands Neulasta label
October 23rd, 2005
Amgen (AMGN) announced that the U.S. Food & Drug Administration (FDA) approved an update to the Neulasta (pegfilgrastim) prescribing information to include data from a landmark phase III study demonstrating that the white blood cell booster helps protect patients with most types of cancer undergoing moderately myelosuppressive chemotherapy from infection, as manifested by febrile neutropenia (low white blood cell count with fever), one of the most serious side effects of chemotherapy. Previously, first and subsequent cycle administration of Neulasta to stimulate production of infection-fighting white blood cells was indicated for patients receiving myelosuppressive...
Source: Medical Letter on the CDC & FDA (2005-10-23)
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