Aranesp dosed every three weeks achieved and maintained target hemoglobin levels
May 16, 2005 - 8:26:38 PM
Amgen Inc., (NASDAQ: AMGN) the world's largest biotechnology company, today announced that new interim data from a single-arm, open label study of 1,225 cancer patients receiving chemotherapy demonstrated that Aranesp® (darbepoetin alfa) administered every three weeks was effective in increasing and maintaining patient hemoglobin levels to the recommended target of greater than or equal to 11 g/dL. Further, treatment with Aranesp reduced the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia. The results of the study were presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). [Abstract #8129]
"Chemotherapy is most often administered every three weeks. Our results suggest that every-three-week dosing of Aranesp at 300 mcg may allow physicians to effectively combine anemia treatment on the same schedule as chemotherapy," said Ralph Boccia, M.D., clinical associate professor of medicine, Georgetown University Medical Center. "This may improve patient convenience without sacrificing efficacy."
In the interim analysis of 1,225 cancer patients receiving 300 mcg of Aranesp every three weeks, 91 percent of patients achieved a target hemoglobin of greater than or equal to 11 g/dL, and 72 percent of patients maintained the target hemoglobin level. The mean hemoglobin was 11.5 g/dL after achieving target hemoglobin. From week five to the end of the study (week 16), only 20 percent of patients required red blood cell transfusion. The number and type of adverse events were consistent with the adverse event profile for this population of anemic cancer patients receiving Aranesp.
In May, Amgen announced submission of a supplemental biologics license application to the U.S. Food and Drug Administration (FDA) for every-three-week dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.
Final results from a Phase 3 head-to-head study of Aranesp 200 mcg administered every two weeks and Epoetin alfa dosed once a week were also presented during the ASCO Annual Meeting. [Abstract #8125]
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