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Spectrum Pharmaceuticals seeks US FDA approval for neutropenia therapy

Spectrum Pharmaceuticals Inc. is seeking U.S. approval for its drug to treat chemotherapy-induced neutropenia.

The Henderson, Nev.-based biotechnology company said it submitted a biologics license application to the U.S. Food and Drug Administration for Rolontis, or eflapegrastim, to treat the condition characterized by an abnormally low level of the white blood cells that are depleted during chemotherapy and which can lead to infection and sepsis.

Two phase 3 studies dubbed Advance and Recover compared Rolontis with Amgen Inc.'s Neulasta, or pegfilgrastim, in over 643 early-stage breast cancer patients and found no meaningful differences between the two therapies, Spectrum Pharmaceuticals said. The Advance study is being conducted under a special protocol assessment with the FDA, which allows for submission of results from incomplete trials for approval.