• THOUSAND OAKS, California—In a phase III study, darbepoetin alfa(Drug information on darbepoetin alfa) (Aranesp) was ineffective in reducing red blood cell (RBC) transfusions in cancer patients with anemia not due to concurrent chemotherapy, and patients receiving darbepoetin had higher mortality. Amgen, maker of Aranesp, informed healthcare professionals of the results in a safety alert letter. The company noted that Aranesp is not FDA approved for use in this population. "Aranesp should be used only in accordance with its approved product labeling for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy," the company said.
In the double-blind, randomized trial, Aranesp was compared with placebo in 989 patients with active malignant disease not receiving or expected to receive chemotherapy or radiation therapy who had hemoglobin levels of 11 g/dL or less. Patients were treated for 16 weeks with a 16-week extension.
The final analysis of the initial 16-week treatment period did not show a significant effect on the primary efficacy endpoint, with an incidence of RBC transfusions of 24% in the placebo group vs 18% in the Aranesp group (HR 0.89, P = .015), the company said. At 16 weeks, more deaths were reported in the Aranesp group (26% vs 20% for placebo). With median survival follow-up of 4.3 months, the absolute number of deaths was greater in the Aranesp group (250 of 515 patients, 49%) vs placebo (216 of 470 patients, 46%) (HR 1.25). Follow-up of surviving patients continues.
"Details of the study will be presented and published in a peer-reviewed setting as soon as possible," Amgen said.
