AMGEN NEUPOGEN IN AML: REDUCED DURATION OF NEUTROPENIA EVENTS SUPPORTS APPROVAL WITHOUT SIGNIFICANT EFFECT ON INCIDENCE, ADVISORY CMTE. AGREES
Executive Summary
Acute myeloid leukemia chemotherapy patients receiving Amgen's Neupogen (filgrastim) in a Phase III trial showed a useful decrease in depth of neutropenia and duration of hospitalization, fever and antibiotic use that would support approval for treatment in AML patients, FDA's Biological Response Modifiers Advisory Committee agreed unanimously on June 25.