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Neulasta (PEGFILGRASTIM)
Neulasta stimulates the production of white blood cells by binding to their receptors.
Neulasta (PEGFILGRASTIM) is a leukocyte growth factor developed by AMGEN, targeting the granulocyte colony-stimulating factor receptor. It is a small molecule modality, FDA-approved in 2002 for allogeneic peripheral blood stem cell transplant and chemotherapy-induced neutropenia. As a patented product, Neulasta remains under AMGEN's ownership. Key safety considerations include potential increased risk of thrombocytopenia and leukocytosis. Neulasta's mechanism of action involves stimulating the production of white blood cells.
At a glance
| Generic name | PEGFILGRASTIM |
|---|---|
| Sponsor | Amgen |
| Drug class | Leukocyte Growth Factor [EPC] |
| Target | Granulocyte colony-stimulating factor receptor |
| Modality | Recombinant protein |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2002 |
Mechanism of action
Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
Approved indications
- Allogeneic peripheral blood stem cell transplant
- Chemotherapy-induced neutropenia
Common side effects
- Bone pain
- Pain in extremity
- Leukocytosis
- Splenic rupture and splenomegaly
- Acute respiratory distress syndrome
- Allergic reactions/hypersensitivity
- Sickle cell crisis
- Glomerulonephritis
- Thrombocytopenia
- Capillary leak syndrome
- Injection site reactions
- Sweets syndrome
Key clinical trials
- Brentuximab Vedotin in Early Stage Hodgkin Lymphoma (PHASE3)
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer (PHASE2,PHASE3)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer (PHASE1,PHASE2)
- Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma (PHASE2)
- Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors (PHASE2)
- ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma (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:
- Neulasta CI brief — competitive landscape report
- Neulasta updates RSS · CI watch RSS
- Amgen portfolio CI