Home » Drug Information » FDA Approved Drugs » 1995
Medical Areas: Endocrinology | Oncology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved on November 24, 1995
Treatment Area: transplantation
Leukine has been shown to increase white blood cells after
autologous and allogeneic bone marrow transplantation as well as
after peripheral blood progenitor cell (PBPC) transplantation.
Leukine, a white blood cell stimulant, is a yeast-derived
granulocyte-macrophage colony stimulating factor. It was originally
licensed by the FDA in March, 1991 for use following autologous
bone marrow transplantation (BMT) and was licensed in December 1991
to prevent death following BMT engraftment delay or failure. It has
subsequently been licensed in September of 1995, to prevent early
death from infection following induction chemotherapy for older
subjects suffering from acute myelogenous leukemia (AML).
In a study of 196 subjects, Leukine given to mobilize PBPCs
significantly increased the number of progenitor cells collected.
When Leukine was given after transplantation with mobilized PBPCs,
there was a further acceleration in white blood cell recovery. In
addition, the number of platelet transfusions and red blood cell
transfusions needed were decreased, subjects were discharged from
the hospital earlier when compared to subjects not receiving
Leukine therapy was generally well tolerated with mild side
Progenitor cells are vital in helping patients recover after
chemotherapy and radiotherapy--two treatments for a variety of
Bone marrow harvesting has been the procedure traditionally used
to obtain progenitor cells from the bone marrow. These same
progenitor cells are present in small quantities in the peripheral
blood and can be collected from peripheral blood through a
procedure called apheresis. By giving a growth factor, such as
Leukine, before apheresis, the number of progenitor cells in
peripheral blood can be enhanced and the number of progenitor cells
in peripheral blood can be enhanced and the number of apheresis
procedures can be decreased.
After a subject’s progenitor cells are collected by apheresis,
the cells are stored and later reinjected after high-dose
chemotherapy with or without total body irradiation, to help
repopulate the bone marrow. Using this procedure, larger numbers of
PBPCs are collected which leads to more rapid engraftment.
Apheresis is less invasive than bone marrow harvesting and requires
no anesthesia. Therefore, using PBPC to repopulate the marrow
following high-dose chemotherapy and/or radiotherapy is replacing
the use of bone marrow progenitor cells in many settings.