Evidenced-Based Support for the Treatment of Potentially Lethal Radiation-Induced Organ-Specific and Multiple-Organ System Sequelae

Thomas J. MacVittie PhD & Ann M. Farese PhD
Department of Radiation Oncology, University of Maryland School of Medicine
Baltimore Maryland USA

Abstract

There are no FDA-approved medical counter-measures (MCM) for the treatment of potentially, lethally-irradiated personnel, consequent to a nuclear terrorist event. However, there are several cytokines that will likely be used as MCM under an emergency use authorization (EUA). The decision to administer the MCM will be evidence-based along a path similar to that required for FDA approval of a MCM under guidance documents for use of the FDA animal rule (AR) and the EUA. Animal models are required that define the dose response and time course of respective organ-specific sequelae and multiple organ system involvement in the acute and delayed radiation syndromes. In addition to cytokines, the development of current and new generation drugs and biologics include small molecules and cell-based therapies focused on an array of targets that may mitigate and/or treat the morbidity and mortality associated with the ARS. Current and new generation MCM will be discussed relative to the evidence-based data requirements of the FDA AR and effective use after a nuclear terrorist event.