LEUKINE
Leukine (sargramostim) is a leukocyte growth factor used to accelerate myeloid reconstitution and reduce the risk of severe infections in patients undergoing chemotherapy or bone marrow transplantation. It is indicated for adult and pediatric patients following autologous or allogeneic transplants, as well as for older adults with acute myeloid leukemia after induction therapy. Additionally, the drug is used to mobilize hematopoietic progenitor cells for collection and to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
How LEUKINE Works
Sargramostim is a colony-stimulating factor that binds to specific receptors on the surface of target cells to support the survival and differentiation of hematopoietic progenitor cells. It induces these cells to divide and mature into neutrophils, monocytes, macrophages, and myeloid-derived dendritic cells. The drug also activates mature granulocytes and macrophages, increasing their ability to inhibit tumor growth and respond to infections.
Details
- Status
- Prescription
- First Approved
- 1991-03-05
- Routes
- N/A
- Dosage Forms
- VIAL
LEUKINE Approval History
What LEUKINE Treats
6 indicationsLEUKINE is approved for 6 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute myeloid leukemia following induction chemotherapy
- Mobilization of hematopoietic progenitor cells for autologous transplantation
- Acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation
- Acceleration of myeloid reconstitution following allogeneic bone marrow transplantation
- Delayed neutrophil recovery or graft failure after bone marrow transplantation
- Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS)
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LEUKINE FDA Label Details
ProIndications & Usage
FDA Label (PDF)LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.