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Neulasta® (pegfilgrastim)
Pegfilgrastim stimulates the proliferation and differentiation of neutrophil progenitor cells in bone marrow to increase circulating neutrophil counts.
Pegfilgrastim stimulates the proliferation and differentiation of neutrophil progenitor cells in bone marrow to increase circulating neutrophil counts. Used for Chemotherapy-induced neutropenia (CIN) in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy, Severe chronic neutropenia (SCN), Mobilization of peripheral blood progenitor cells for autologous transplantation.
At a glance
| Generic name | Neulasta® (pegfilgrastim) |
|---|---|
| Sponsor | Amgen |
| Drug class | Granulocyte colony-stimulating factor (G-CSF) analog |
| Target | G-CSF receptor (GCSFR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Pegfilgrastim is a long-acting granulocyte colony-stimulating factor (G-CSF) analog that binds to G-CSF receptors on hematopoietic cells. By activating these receptors, it promotes the growth, differentiation, and activation of neutrophil precursors, leading to increased production and release of mature neutrophils into the bloodstream. The pegylation extends its half-life, allowing for less frequent dosing compared to filgrastim.
Approved indications
- Chemotherapy-induced neutropenia (CIN) in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy
- Severe chronic neutropenia (SCN)
- Mobilization of peripheral blood progenitor cells for autologous transplantation
Common side effects
- Bone pain
- Fatigue
- Headache
- Nausea
- Splenic rupture (rare)
- Acute respiratory distress syndrome (rare)
Key clinical trials
- Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors (PHASE2)
- Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia (PHASE2)
- Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma (PHASE2)
- Diabetes Islet Preservation Immune Treatment (PHASE1, PHASE2)
- Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy (PHASE2)
- Mature B-Cell Lymphoma And Leukemia Study III (PHASE2, PHASE3)
- Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy (PHASE3)
- Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies (PHASE2)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Neulasta® (pegfilgrastim) CI brief — competitive landscape report
- Neulasta® (pegfilgrastim) updates RSS · CI watch RSS
- Amgen portfolio CI