Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee Meeting

Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee Meeting Committee Meeting May 3, 2013 8:00 a.m. to 5:00 p.m. Agenda: The committees will discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. (Myelosuppression is a reduction of blood cell production, which can be caused by radiation exposure.) Currently approved LGFs are licensed under biological license applications (BLAs): 103353, NEUPOGEN (filgrastim, Amgen, Inc.), 125031, NEULASTA (pegfilgrastim, Amgen, Inc.), 103362, LEUKINE (sargramostim, Genzyme, Inc.), and 125294, TBO-FILGRASTIM (tbo-filgrastim, Sicor Biotech, UAB). The National Institute of Allergy and Infectious Diseases (NIAID) has submitted efficacy data for filgrastim, based on treatment in an animal model of radiation-induced myelosuppression. Safety and other supportive information are currently described in the labeling for LGFs.