LYON, FRANCE, June 16, 2003 - Amgen (Nasdaq:AMGN), the world's largest biotechnology company, presented data showing that three times as many anemic patients with lymphoid cancers receiving Aranesp® (darbepoetin alfa) experienced increases in hemoglobin levels compared to those receiving placebo. These data support the recent recommendation by the European Committee on Proprietary Medicinal Products (CPMP) to extend the Aranesp® label to include treatment of chemotherapy-induced anemia in adult patients with non-myeloid malignancies. Results from the study were presented at the European Hematology Association meeting by Michael Hedenus, MD, of Sundsvall Hospital, Sundsvall, Sweden.
"Our study addressed the question of whether myelomas responded better than lymphomas to treatment with erythropoietic proteins. We found that Aranesp® was equally efficacious in patients with myeloma and lymphoma," said Dr. Hedenus. "Given the prevalence of anemia among chemotherapy patients, these data provide important insight into how doctors can best manage this serious and debilitating condition."
In the multi-center double-blind trial, 349 adults with lymphoid system cancers and hemoglobin levels ≤11.0g/dL were randomized to receive Aranesp® or placebo for
12 weeks. Dr. Hedenus reported that, overall, 60 percent of patients receiving Aranesp® achieved an increase in hemoglobin of ≥2.0 g/dL from baseline, compared to only 18 percent in the placebo group, (p<0.001). Patients receiving Aranesp® also experienced higher mean changes in hemoglobin compared to placebo. Participants who received red blood cell transfusion in the preceding 28 days were not included in the analysis.
"In addition to effectively correcting anemia, we also noted that patients receiving Aranesp® experienced clinically significant improvements in fatigue," said Dr. Hedenus.
The most frequently reported adverse events were consistent with those previously observed with darbepoetin alfa in this patient population (i.e., gastrointestinal and constitutional symptoms associated with chemotherapy).
Cancers of the lymphoid system (sometimes called lymphoproliferative diseases) include Hodgkin's disease, non-Hodgkin's lymphomas, chronic lymphocytic leukemia and multiple myeloma. Anemia induced by chemotherapy is particularly prevalent in these cancers, with up to 80 percent of patients developing it in the course of their disease. (Birgegard)
CPMP Recommends Extending the Aranesp® Label
Aranesp® is currently licensed in Europe for once-weekly treatment of chemotherapy-induced anemia in adults with solid tumors. Recently, the CPMP recommended extending this label to include treatment of chemotherapy-induced anemia in adult patients with non-myeloid malignancies. This encompasses solid and lymphoid cancers but excludes rare myeloid leukemia-related conditions. The new data suggest that chemotherapy-induced anemia could now be effectively treated with once weekly therapy in approximately 93 percent of all cancers. (Bray, et al)
"When this recommendation is approved by the European Commission, Aranesp® will be the only once weekly erythropoietic agent indicated for chemotherapy-induced anemia in such a wide range of cancers, irrespective of chemotherapy regimen," said Keith Leonard, vice president and general manager, Amgen (Europe) AG.
Aranesp® is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events; dose reductions are recommended if the hemoglobin increase exceeds 1.0 g/dL in any 2-week period have been associated with serious side effects. The most commonly reported side effects in Aranesp® trials were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea.
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Note: Copies of the study abstracts are available upon request. Full prescribing information is available on the Web for Aranesp® at www.aranesp.com.