FDA Approves Third Countermeasure for Acute Radiation Syndrome
The Food and Drug Administration (FDA) has approved the use of Leukine (sargramostim; Sanofi Genzyme) to increase survival in children and adults exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome [H-ARS]).
Leukine, a granulocyte-macrophage colony stimulating factor (recombinant), was originally approved in 1991 to reduce time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections after induction chemotherapy in adults aged ≥55 years with acute myeloid leukemia (AML). Since then, it has gained the following indications: to mobilize hematopoietic progenitor cells into peripheral blood for collection by leukapheresis; to speed myeloid recovery in non-Hodgkin's lymphoma, acute lymphoblastic leukemia (ALL), and Hodgkin's disease in autologous bone marrow transplantation (BMT); to speed myeloid recovery in allogeneic BMT; for use in patients with BMT failure or engraftment delay.
Leukine is the third approved countermeasure intended to increase survival in patients with H-ARS. The FDA approval was supported by efficacy studies in animals as they could not be ethically conducted in humans. When administered up to 48 hours after total body irradiation exposure, there was an increased survival in 50% of exposed patients at doses expected to be fatal, who were under minimal supportive care.
For more information call (888) 463-6332 or visit FDA.gov.