Amgen reported 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, of Sundsvall Hospital, Sundsvall, Sweden.

In the multi-center double-blind trial, 349 adults with lymphoid system cancers and hemoglobin levels < / = 11.0g/dL were randomized to receive Aranesp(R) 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.

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.

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.