Spectrum Pharmaceuticals Inc. submitted an updated biologics license application to the U.S. Food and Drug Administration for Rolontis after voluntarily withdrawing an earlier submission in March.
The Henderson, Nev.-based biotech is seeking approval for its blood disorder drug Rolonits, or eflapegrastim, to treat chemotherapy-induced neutropenia. Neutropenia is an abnormally low concentration of neutrophils, a type of white blood cell, in the blood due to chemotherapy. The destruction of these cells leaves the body vulnerable to infections.
Spectrum, which develops therapies to treat cancer and blood disorders, initially submitted an application with the FDA in December 2018 but withdrew it after the U.S. regulator requested additional manufacturing-related information for the medicine. The updated application includes additional information regarding chemistry, manufacturing and controls.
The application is based on results from two phase 3 studies dubbed Advance and Recover that showed Rolontis and Amgen Inc.'s Neulasta, or pegfilgrastim, had no meaningful differences.