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Aranesp Phase 3 Study in Patients with Active Cancer Not Receiving,Concurrent Chemotherapy or Radiotherapy Presented at AACR Annual,Meeting

r IV (82 percent) and an ECOG status of 0 or 1 (72 percent); and baseline Hb was 9.5 g/dL in each group.

However, there were more men in the Aranesp group (56 percent) compared to the placebo group (47 percent) and overall survival was worse for men than women (hazard ratio: 1.38 versus 0.99, respectively). More patients received prior chemotherapy in the Aranesp group (73 percent versus 66 percent in placebo). The mean (SD) number of days between prior chemotherapy and first study drug dose was 262 (572) days for the Aranesp group compared to 315 (660) for the placebo arm.

About Aranesp

Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia associated with chronic renal failure (CRF), also known as chronic kidney disease (CKD), for patients on dialysis and patients not on dialysis. In July 2002, the FDA approved weekly dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies and in March 2006, the FDA approved every-three-week dosing in these patients.

Important Safety Information

Use the lowest dose of Aranesp that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusion (see DOSAGE and ADMINISTRATION in the prescribing information).

Aranesp and other erythropoiesis-stimulating agents (ESAs) increased the risk for death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/dL (see WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events).

Cancer Patients: Use of ESAs

-- shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a hemoglobin of greater than 12 g/dL;

-- shortened overall survival and increased deaths attributed to disease progression at 4 months in patien
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