Darbepoetin alfa (Aranesp).

BUMC PROCEEDINGS 2002;15:332–335 The Food and Drug Administration (FDA) approved darbepoetin alfa (Aranesp) for treatment of anemia as sociated with chronic renal failure (CRF) in patients on dialysis and patients not on dialysis (1). The manufacturer of the drug also filed an application with the FDA on September 18, 2001, to receive an indication for treatment of anemia in patients with cancer (Robert Hunter, Amgen Medical Affairs, personal communication, January 31, 2002). During development, the compound was called novel erythropoiesis stimulating protein, or NESP. Anemia is defined as a reduction in hemoglobin or a reduction in the number of circulating red blood cells (2). Anemia has been further categorized by severity by several groups, including the National Cancer Institute and the World Health Organization (Table 1). A normocytic, normochromic anemia is present in most patients with chronic renal disease and is usually observed when the glomerular filtration rate falls below 30 mL/min (5). Groopman and Itri reported that despite limitations in grading and reporting, the incidence of chemotherapy-related mild to moderate anemia in patients with cancer was relatively high. They explained that although historically such anemias have gone untreated, new data suggest that treatment results in significant improvements in quality of life measures for these patients (3).