Phase 3 study produce's favourable results for Amgen's Aranesp

Amgen says the results of a Phase III randomised, open-label head-to-head study demonstrated that Aranesp, dosed every two weeks resulted in similar clinical efficacy as Epoetin alfa dosed once a week, boosting haemoglobin levels and reducing the need for red blood cell transfusions in cancer patients with chemotherapy-induced anaemia. The results of the study have been published in the May 20th issue of The Journal of Clinical Oncology.

Amgen's anaemia treatment Epoetin alfa, is a recombinant erythropoietin, a protein that stimulates the production of oxygen-carrying red blood cells, however, its new drug Aranesp is a erythropoiesis-stimulating protein that can be dosed less frequently.

Aranesp was approved by the US Food and Drug Administration (FDA) in 2001 for the treatment of anaemia associated with chronic renal failure (CRF), for patients on dialysis and patients not on dialysis. In 2002, it was also approved in the US for the treatment of chemotherapy-induced anaemia in patients with non-myeloid malignancies.

"Results of this study, the largest, randomised head-to-head comparison of darbepoetin alfa dosed every two weeks to weekly Epoetin alfa, showed that fewer injections did not compromise efficacy with respect to decreased transfusion requirements," said John Glaspy, professor, David Geffen School of Medicine, University of California at Los Angeles. "From a clinician perspective, the comparability in patient reported outcomes, including energy levels and impact on daily activities, provide further evidence that we can extend dosing intervals and represents an important potential benefit for patients and their caregivers."

This year, an estimated 1.3m cancer patients will undergo chemotherapy in the US and approximately 800,000 (67%) of those will become anaemic.