LEUKINE
LOE Approachingsargramostim
BLAINTRAVENOUSVIALPriority Review
Approved
Mar 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
LEUKINE (sargramostim) is (gm-csf) belongs to a group of growth factors termed colony-stimulating factors which support survival, clonal expansion, and differentiation of hematopoietic progenitor cells. First approved in 1991.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEUKINE (sargramostim) is a recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF) that promotes survival, proliferation, and differentiation of hematopoietic progenitor cells across multiple lineages including neutrophils, monocytes, and dendritic cells. It is indicated for a broad spectrum of hematologic malignancies, solid tumors, immunodeficiency conditions, and inflammatory diseases. The drug works by binding to GM-CSF receptors on target cells to induce cellular division, maturation, and activation with multilineage hematopoietic effects.
$3MPart D
LOE ApproachingDeclining
As a biologics franchise approaching LOE with modest Part D uptake ($3M annually), LEUKINE teams are likely managing defensive strategies against biosimilar entry and competing with higher-spending oncology and immunology platforms.
Mechanism of Action
(GM-CSF) belongs to a group of growth factors termed colony-stimulating factors which support survival, clonal expansion, and differentiation of hematopoietic progenitor cells. GM-CSF induces partially committed progenitor cells to divide and differentiate in the granulocyte-macrophage pathways…
Pharmacologic Class:
Leukocyte Growth Factor
Indications
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.