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Leukine (SARGRAMOSTIM)
Leukine works by binding to the granulocyte macrophage colony-stimulating factor receptor, stimulating the production of white blood cells.
Leukine (SARGRAMOSTIM) is a leukocyte growth factor that targets the granulocyte macrophage colony-stimulating factor receptor. It is a small molecule drug class that was originally developed by Berlex Labs and is currently owned by the same company. Leukine was FDA-approved in 1991 for the treatment of chemotherapy-induced neutropenia. The commercial status of Leukine is patented, and it is used to stimulate the production of white blood cells in patients undergoing chemotherapy. Key safety considerations include the potential for injection site reactions and allergic reactions.
At a glance
| Generic name | SARGRAMOSTIM |
|---|---|
| Sponsor | Berlex Labs |
| Drug class | Leukocyte Growth Factor [EPC] |
| Target | Granulocyte macrophage colony-stimulating factor receptor |
| Modality | Recombinant protein |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1991 |
Mechanism of action
Sargramostim (GM-CSF) belongs to 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 which include neutrophils, monocytes/macrophages and myeloid-derived dendritic cells.GM-CSF is also capable of activating mature granulocytes and macrophages. GM-CSF is multilineage factor and, in addition to dose-dependent effects on the myelomonocytic lineage, can promote the proliferation of megakaryocytic and erythroid progenitors. However, other factors are required to induce complete maturation in these two lineages. The various cellular responses (i.e., division, maturation, activation) are induced through GM-CSF binding to specific receptors expressed on the cell surface of target cells.The biological activity of GM-CSF is species-specific. Consequent
Approved indications
- Chemotherapy-induced neutropenia
Common side effects
- Fever
- Nausea
- Diarrhea
- Vomiting
- Anorexia
- Edema
- Alopecia
- Rash
- Mucous membrane disorder
- Asthenia
- Malaise
- Gastrointestinal disorder
Key clinical trials
- Testing the SurVaxM Vaccine for Lung Cancer Prevention (PHASE2)
- Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse (PHASE1,PHASE2)
- A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma (PHASE2,PHASE3)
- SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (PHASE2)
- NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial (PHASE2)
- A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients (PHASE2)
- Pilot Study of the Effect of Trastuzumab and GM-CSF on Children With Recurrent Ependymoma (PHASE1)
- A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Leukine CI brief — competitive landscape report
- Leukine updates RSS · CI watch RSS
- Berlex Labs portfolio CI