Home » Drug Information » Recently Approved Drugs » 1996
Medical Areas: Hematology | Immunology/Infectious Diseases | Oncology
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Immunex
Approval Status: Approved November 1996
Treatment Area: replenishment of white blood cells, fungal infections
A new liquid, multiple-dose formulation of Leukine has been
approved. Leukine, a yeast-expressed granulocyte-macrophage colony
stimulating factor (GM-CSF), has been available in the United
States since 1991.
Leukine helps older adult leukemia subjects’ white blood cells
recover quickly, and it helps prevent life-threatening infections,
including fungal infections, which often complicate their recovery
and increase their risk of complications. A liquid formulation is
designed for easier use in the hospital or clinic and will be
simpler for subjects to administer at home.
Leukine Liquid will be available initially in a 500-mcg-vial
size. Immunex will continue marketing the 250 mcg and 500 mcg
lyophilized product.
GM-CSF is an immune modulator that stimulates production and
function of white blood cells that are vital for preventing
life-threatening infections, especially fungal infections. Leukine
is used for bone marrow and peripheral blood progenitor cell
transplantations, and the exclusive indication for the treatment of
chemotherapy-induced neutropenia in older adult subjects with acute
myelogenous leukemia.