FDA Clears Extended Dosing of Darbepoetin for Chemotherapy-Induced Anemia

Amgen recently announced the US Food and Drug Administration (FDA) has approved every-3-week dosing of darbepoetin alfa (Aranesp) for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. Darbepoetin is the only erythropoiesis-stimulating agent approved by the FDA for every-3-week administration.

"Amgen developed Aranesp to provide cancer patients with a long-acting and effective means to treat chemotherapy-induced anemia, a common side effect of chemotherapy," said Willard Dere, MD, chief medical officer and senior vice president of Global Development at Amgen. "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. This offers improved convenience for patients and less injection-related burden for patients and health-care professionals compared to weekly anemia treatment."

Reducing Frequency of Clinic Visits

Frequent visits to the clinic for anemia treatment can result in significant time spent by patients, caregivers, and health-care providers. Reducing the number of visits required for anemia treatment with less frequent dosing and trying to synchronize anemia treatment with other naturally occurring visits could reduce the amount of patient and caregiver time required for anemia treatment.

"In clinical studies, Aranesp has proven effective in reducing the incidence of red blood cell transfusions and boosting and maintaining target hemoglobin levels when administered every 3 weeks," said Ralph Boccia, MD, director of clinical research, Center for Cancer and Blood Disorders, Bethesda, Md. "This less frequent dosing means patients can visit the doctor less frequently, which can result in less time away from loved ones and daily activities."

Phase III Trial

The update to the darbepoetin label now includes a recommended starting dose of 500 µg once every 3 weeks in addition to the recommended starting dose of 2.25 µg/kg once weekly. The new dosing recommendations are based on a randomized, double-blind, phase III study that evaluated the safety and effectiveness of every-3-week administration of darbepoetin. Patients with chemotherapy-induced anemia were randomized to receive 500 µg of darbepoetin every 3 weeks (n = 353) or 2.25 µg/kg (n = 352) administered weekly for up to 15 weeks.

In both groups, the starting dose was reduced by 40% if hemoglobin levels increased by more than 1 g/dL in a 14-day period, and darbepoetin was withheld if hemoglobin levels exceeded 13 g/dL. More than 70% of patients in the every-3-week group required dose reductions, resulting in an average weekly dose of 125 µg for the patients in this group.