On Feb. 22, 1991, the Food and Drug Administration (FDA) announced that it had approved Amgen’s two white blood cell colony-stimulating factors (G-CSF- NEUPOGEN) and (GM-CSF) for the treatment of congenital and acquired neutropenias and for mobilization of peripheral hematopoietic progenitor cells for stem cell transplantation.

Neutropenia refers to lower-than-normal levels of neutrophils in your blood. A neutrophil is a type of white blood cell that your bone marrow primarily makes. White blood cells in general, and neutrophils in particular, fight infections in your body. Cloning of human GM-CSF and its expression in bacterial and eukaryotic cells was achieved in 1985 at Genetics Institute, and, a year later, G-CSF and its expression in E. coli at Amgen.

GM-CSF is currently approved by the FDA to accelerate myeloid recovery in patients with non-Hodgkin’s lymphoma, acute lymphoblastic leukemia, and Hodgkin’s disease undergoing autologous stem cell transplantation; following induction chemotherapy in older adult patients with AML to shorten time to neutrophil recovery and reduce the incidence of life-threatening infections; to accelerate myeloid recovery in patients undergoing allogeneic stem cell transplantation from HLA- matched related donors; for patients who have undergone allogeneic or autologous stem cell transplantation in whom engraftment is delayed or failed; and to mobilize hematopoietic progenitor cells into peripheral blood for collection by leukapheresis. Forms of GM-CSF available worldwide are sargramostim and molgramostim.