Aranesp Approved for Treatment of Chemotherapy-Induced Anemia

THOUSAND OAKS, California—The US Food and Drug Administration has approved Amgen’s Aranesp (darbepoetin alfa) for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. Aranesp, a recombinant erythropoietic protein, has a half-life approximately three times longer than that of epoetin alfa (Epogen, Procrit); thus, fewer injections are required by the patient.

The FDA originally approved Aranesp in September 2001 for the treatment of anemia associated with chronic renal failure in patients on or not on dialysis.

Clinical studies showed that patients suffering from chemotherapy-related anemia who received Aranesp consistently reached target hemoglobin levels, and the agent was generally well tolerated, the company said in a news release announcing the approval.

"Aranesp not only helps correct anemia and maintain hemoglobin levels during chemotherapy, but also helps chemotherapy patients and their physicians overcome barriers that can hinder the delivery of current anemia treatment, notably the need for frequent office visits," said Robert E. Smith, Jr., MD, president of South Carolina Oncology Associates and an Aranesp investigator.

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. The most commonly reported side effects in Aranesp trials were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea. No significant differences were observed between Aranesp and epoetin alfa.