Spectrum Pharmaceuticals Inc. voluntarily withdrew its application seeking approval of its drug Rolontis to treat a blood disorder after the U.S. Food and Drug Administration requested additional manufacturing-related information for the medicine.
Henderson, Nev.-based Spectrum submitted a biologics license application in December 2018 for Rolontis, 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 said in its March 15 press release that the FDA did not cite concerns related to the clinical modules of the application or the need for any additional clinical studies.
The company voluntarily withdrew its application as it needed more time to provide certain manufacturing-related information before March 29, the date when the FDA's initial 60-day review period ends.
Spectrum's President and CEO Joe Turgeon said the company was having discussions with the FDA and will resubmit the application with the required information.