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Darbepoetin Study Demonstrates No Statistically Significant Difference in Risk of Death for Darbepoetin Compared to Placebo
The study demonstrated a significant change in hemoglobin concentration from baseline in favor of Aranesp (a co-primary endpoint). Aranesp-treated patients also experienced a significantly lower risk of blood transfusions (HR: 0.40, 95% CI: 0.29 to 0.55). The overall safety profile, including thromboembolic events, was consistent with that described in the U.S. label.
"The 145 study is a component of Amgen's ongoing pharmacovigilance program designed to evaluate the effect of Aranesp on long-term survival in patients with chemotherapy-induced anemia. This study had higher initiation and maintenance hemoglobin targets (Hb less than or equal to 13 g/dl) than in the U.S. label," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "These results contribute to the growing body of evidence on ESA safety, reinforcing the neutral impact of ESAs on survival in cancer patients suffering from chemotherapy-induced anemia."
Amgen initiated the SCLC study in 2002 after results from a previous Phase 3 study showed a trend towards improved survival in patients with lung cancer. The 145 study was designed to evaluate whether increasing or maintaining hemoglobin concentrations with Aranesp, when administered with platinum-containing chemotherapy in patients with previously untreated extensive-stage SCLC, increased survival.
In this study, patients were randomized 1:1 to receive Aranesp 300 mcg or placebo every week (QW) for the first 4 weeks, followed by once every three week (Q3W) dosing (commencing on week 5) for the remainder of the 24-week treatment period. Patients were treated to a target Hb of 13 g/dL, which is higher than indicated by the FDA-approved product label, with dose withholding at 14 g/dL.
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 anemia in patients with nonmyeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy, and in March 2006, the FDA approved every-three-week dosing in these patients.