Sargramostim

Pharmaceutical drug

Sargramostim (tradename Leukine) is a recombinant granulocyte macrophage colony stimulating factor (GM CSF) that functions as an immunostimulator.

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. Additionally, it is used as a medical countermeasure for treating people who have been exposed to sufficient radiation to suppress bone marrow myelogenesis. It is administered via intravenous infusion or via subcutaneous injection. Immunex developed GM CSF manufactured in yeast into Leukine. 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. The upward trend in adverse reaction reporting rates had not been observed with the use of lyophilized sargramostim. The original liquid formulation without EDTA was returned to the market in the US in May 2008. In 2009, Genzyme acquired the rights to Leukine from Bayer, including the manufacturing facility in the Seattle area. In March 2018 the label was extended to use as a countermeasure for acute radiation syndrome. On February 1, 2018, Partner Therapeutics, Inc. acquired the global rights to develop, manufacture, and commercialize Leukine (sargramostim) from Sanofi.