06.06.2005 – 18:31
Final Results of a Phase 3 European Study Demonstrate Aranesp(R) Dosed Once Every Three Weeks is at Least as Effective as Weekly Dosing in Treating Patients With Chemotherapy-Induced Anaemia
Amgen Inc., (NASDAQ: AMGN) the world's largest biotechnology company, announced that new data from a randomised, double-blind Phase 3 study demonstrate that Aranesp(r) (darbepoetin alfa) administered as a fixed dose of 500 mcg once every three weeks is at least as effective as 2.25 mcg/kg of darbepoetin alfa administered once weekly with respect to the need for red blood cell transfusions in cancer patients with chemotherapy-induced Anaemia and is effective in increasing haemoglobin to Evidence Based Practice Guidelines target levels. The results were presented at the 10th Congress of the European Hematology Association. [Abstract #471]
In 2004, darbepoetin alfa was approved by the European Committee for Medicinal Products for Human Use (CHMP) for every-three-week dosing in patients with chemotherapy-induced Anaemia.
"Anaemia is one of the most common side effects of chemotherapy. However, it is often under-treated, despite the availability of treatments that have been available for more than a decade," said Jean-Luc Canon, MD, Centre Notre Dame et Reine Fabiola, Charleroi, Belgium. "The every three-week dosing schedule of Aranesp is consistent with most chemotherapy regimens and may allow physicians to effectively treat Anaemia while reducing the time spent by patients, physicians and caregivers for Anaemia management."
In this study, patients with chemotherapy-induced Anaemia from 110 centres in Europe were randomised to receive either a fixed dose of 500 mcg of darbepoetin alfa every three weeks or 2.25 mcg/kg of darbepoetin alfa once a week. Of the 672 patients assessed from week five through the end of the treatment period, the difference between treatment groups was 6.8 percent with respect to the need for red blood cell transfusion (23 percent of patients receiving darbepoetin alfa once every three weeks compared to 30 percent who received once weekly dosing). Additionally, from week five through the end of the treatment period, 82 percent of patients receiving darbepoetin alfa every three weeks compared to 70 percent of patient receiving darbepoetin alfa once a week achieved the target haemoglobin range (11 to 13 g/dL) consistent with the current evidence based practice guidelines issued by the European Organisation for Research and Treatment of Cancer, American Society of Clinical Oncology, American Society of Hematology and the National Comprehensive Cancer Network.
There were no differences in the safety profile between the two treatment groups. The most frequently reported adverse events were nausea, vomiting, fatigue and pyrexia.
Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized Anaemia treatment with the development of recombinant erythropoietin, Epoetin alfa. Building on this heritage, Amgen developed Aranesp, a unique erythropoiesis stimulating protein, which contains two additional sialic acid-containing carbohydrate chains than the Epoetin alfa molecule and remains in the bloodstream longer than Epoetin alfa because it has a longer half-life. By virtue of its longer half-life, Aranesp should be administered less frequently than Epoetin alfa in patients with chronic kidney disease (CKD).
Darbepoetin alfa was initially granted marketing authorization by the European Commission in 2001 for the treatment of Anaemia associated with chronic renal failure in adults and paediatric subjects 11 years of age or older. In 2002, the European Commission approved darbepoetin alfa for the treatment of Anaemia in adult cancer patients receiving chemotherapy with solid tumours. This patient population was subsequently expanded in 2003 to include all adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Important Safety Information
Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events; regional guidelines should be referred to for target and maximum haemoglobin levels, and dose adjustment rules should be performed in line with regional prescribing information. In a study with another erythropoietic product, where the target Hb was 12-14 g/dL, an increased incidence of thrombotic events, disease progression and mortality was seen.
Pure red cell aplasia (PRCA) has been observed in patients treated with recombinant erythropoietic proteins. This has been reported predominantly in patients with chronic renal failure. Aranesp should be discontinued in any patient with evidence of PRCA and the patient evaluated for the presence of antibodies to erythropoietin products. The most commonly reported side effects in clinical trials were fatigue, edema, nausea, vomiting, diarrhoea, fever and dyspnea.
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 Evidence based Practice Guidelines target level is 11 to 13 g/dL according to the European Organisation for Research and Treatment of Cancer, the National Comprehensive Cancer Network and the American Society of Clinical Oncology.
ots Originaltext: Amgen Inc.
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