Sargramostim
| Clinical data | |
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| Trade names | Leukine |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a693005 |
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| DrugBank | |
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| Chemical and physical data | |
| Formula | C639H1006N168O196S8 |
| Molar mass | 14434.5 g/mol |
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Sargramostim (marketed by Genzyme under the tradename Leukine) is a recombinant granulocyte macrophage colony-stimulating factor (GM-CSF) that functions as an immunostimulator.
It is produced in yeast.
Sargramostim is primarily used for myeloid reconstitution after autologous or allogeneic bone marrow transplantation. It is also used to treat neutropenia induced by chemotherapy during the treatment of acute myeloid leukemia. Sargramostim has recently shown promise in treating Crohn's disease and other GI inflammatory disorders. This medication is being investigated in trials to treat autoimmune pulmonary alveolar proteinosis (PAP). It is also being investigated in combination with oncolytic reovirus in brain cancer.
Sargramostim should not be used in patients with excessive leukemic myeloid blasts in the bone marrow or peripheral blood (≥ 10%), in patients with known hypersensitivity to GM-CSF, yeast-derived products or any component of the product and for concomitant use with chemotherapy and radiotherapy.
The sequence of human GM-CSF was first identified in 1985 and soon three recominbant human GM-CSFs were produced, one in bacteria, one in mammalian cells, and one in yeast;Immunex developed GM-CSF manufactured in yeast into Leukine. Clinical trials of sargramostim were initiated in 1987; in that same year it was administered to six people as part of a compassionate-use protocol for the victims of cesium irradiation from the Goiânia accident.
It was approved by the FDA in March 1991 under the trade name Leukine for acceleration of white blood cell recovery following autologous bone marrow transplantation in patients with non-Hodgkin's lymphoma, acute lymphocytic leukemia, or Hodgkin's disease. In November 1996, the FDA also approved sargramostim for treatment of fungal infections and replenishment of white blood cells following chemotherapy. A liquid formulation was approved in 1995. Immunex was acquired by Amgen in 2002. As part of the acquisition, Leukine was spun off to Berlex, which became Bayer HealthCare in 2007. In 2009, Genzyme acquired the rights to Leukine from Bayer, including the manufacturing facility in the Seattle area.
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