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Amgen Aranesp oncology indication

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Amgen's Aranesp is approved July 19 "for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy." The BLA was submitted Sept. 19, 2001, and was based on a 12-week, 314-patient trial. Updated labeling contains an emphasis on the less frequent dosing of darbepoetin alfa compared to epoetin alfa (Amgen's Epogen, J&J's Procrit). Amgen will detail the product with its oncology products Neupogen (filgrastim) and Neulasta (pegfilgrastim

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