THOUSAND OAKS, CaliforniaThe 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 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
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.