TABLE 1.
US FDA-approved growth factors for other indications repurposed for H-ARS as radiomitigators.
| FDA-approved drugs | Indications of earlier approval | Repurposed indication | Date of repurpose | Comments | References* |
|---|---|---|---|---|---|
| Neupogen/filgrastim/G-CSF | Five different indications of neutropenia and for mobilization of autologous hematopoietic progenitors | Adult patients of H-ARS | March 2015 | Requires full supportive care: blood products and individualized antibiotics; can be delayed up until 24 h after irradiation | Farese and MacVittie (2015); U.S. Food and Drug Administration (2015); Amgen Inc. (2015) |
| Neulasta/PEGylated filgrastim/PEGylated G-CSF | Decreases infections as displayed by febrile neutropenia | Adult and pediatric patients of H-ARS | November 2015 | Needs full supportive care: blood products and personalized antibiotics; can be delayed until one day after irradiation | National Institute of Allergic and Infectious Diseases (2015); Amgen Inc. (2015) |
| Leukine/sargramostim/GM-CSF | Five different indications for shortening time to neutrophil recovery, mobilization of hematopoietic progenitors, acceleration of myeloid reconstitution, and treatment of delayed neutrophil recovery | Adult and pediatric patients of H-ARS | March 2018 | Requires minimal supportive care: antibiotics and fluid; can be delayed until 48 h after irradiation | U.S. Food and drug Administration (2018); Singh and Seed (2018); Sanofi-Aventis U.S. LLC (2018); Gale and Armitage (2021); Zhong et al. (2020) |
| Nplate/romiplostim/synthetic TPO | Adult and pediatric patients of immune thrombocytopenia | Adult and pediatric patients of H-ARS | January 2021 | Requires minimal supportive care: antibiotics and fluid; should be administered as soon as possible after suspected or confirmed exposure to radiation | Amgen Inc. (2021); Wong et al. (2020); Wong et al. (2020) |
The NHP studies were performed at different research sites under the control of respective IACUC rules that may well have dictated that studies of lethal effects must include blood transfusions. The specific medical countermeasures was tested with and without blood transfusions as required based on a trigger-to-treat.