FDA Approves New Every-3-Week Dosing for Aranesp

ROCKVILLE, Maryland—The Food and Drug Administration (FDA) has approved a new every-3-week dosing schedule for Amgen's erythropoiesis-stimulating agent Aranesp (darbepoetin alfa) used in the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. Of the estimated 1.3 million cancer patients who will receive chemotherapy in the United States this year, about 800,000 will develop anemia, one of the most common adverse events associated with the treatment of malignancies.

"The approval of an extended-dosing protocol for Aranesp is an important milestone allowing anemia treatment to be synchronized with both weekly and every-3-week chemotherapy, which are the most commonly used treatment regimens," said Willard Dere, MD, Amgen's chief medical officer and senior vice president of global development. "This offers improved convenience for patients and less injection-related burden for patients and health care professionals, compared to weekly anemia treatment."

FDA approved the new dosing recommendation on the basis of a randomized, double-blind, 705-patient, phase III trial. Researchers in the multicenter European study randomized 353 patients to receive 500 μg of Aranesp every 3 weeks and 352 patients to receive 2.25 μg/kg weekly for up to 15 weeks. The protocol called for reducing the starting dose in both study arms by 40% in patients whose hemoglobin levels increased by more than 1 g/dL in a 14-day period, and withholding Aranesp if hemoglobin levels exceeded 13 g/dL. More than 70% of the patients in the every-3-week group required dose reductions, which resulted in a mean average weekly dose of 125 μg in that arm.

The amended labeling for Aranesp recommends a starting dose of 500 μg once every 3 weeks. The previous recommended dosing of 2.25 μg/kg once weekly remains in the labeling.