Product Description
Filgrastim injection products (Granix, Neupogen, Nivestym, Zarxio) are used to decrease the chance of infection in people who have non myeloid cancer (cancer that does not involve the bone marrow) and are receiving chemotherapy medications that may decrease the number of neutrophils (a type of blood cell needed to fight infection). Filgrastim is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils. (Sourced from: https://medlineplus.gov/druginfo/meds/a692033.html)
Mechanisms of Action: G-CSF
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Subcutaneous,Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Febrile Neutropenia | Neutropenia | Acute Leukemia | Acute Myeloid Leukemia | Leukemia | Myeloid Leukemia | Bone Cancer | Oropharyngeal Cancer | Pharyngeal Cancer | Oncology Unspecified | Bone Marrow Transplantation | Stem Cell Transplant | Acute Radiation Syndrome | Acute Leukemia | Acute Myeloid Leukemia | Leukemia | Myeloid Leukemia | Bone Cancer | Oncology Unspecified | Bone Marrow Transplantation | Stem Cell Transplant | Febrile Neutropenia | Neutropenia | Acute Leukemia | Acute Myeloid Leukemia | Leukemia | Myeloid Leukemia | Bone Cancer | Oropharyngeal Cancer | Pharyngeal Cancer | Oncology Unspecified | Bone Marrow Transplantation | Stem Cell Transplant
Known Adverse Events: Chronic Pain | Headache | Pain Unspecified | Alopecia | Anemia | Neutropenia | Acute Myeloid Leukemia | Bone Cancer | Oncology Unspecified | Epistaxis | Dyspnea | Diarrhea
Company: Amgen
Company Location: THOUSAND OAKS CA 91320
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Germany, Hungary, Japan, Netherlands, Poland, United Kingdom, United States
Active Clinical Trial Count: 11
Highest Development Phases
Phase 3: ST Elevation Myocardial Infarction|Sarcoma, Ewing
Phase 2: Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Biphenotypic Acute Leukemia|Hodgkin Lymphoma|Lymphoma|Multiple Myeloma|Myocardial Ischemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma
Phase 1: Astrocytoma|Brain Stem Cancer|Central Nervous System Cancer|Choroid Plexus Cancer|Chronic Myeloid Leukemia|Embryo Loss|Embryonal Carcinoma|Ependymoma|Febrile Neutropenia|Ganglioglioma|Ganglioneuroblastoma|Glioblastoma|Hot Flashes|Medulloblastoma|Meningioma|Myelodysplastic Syndrome|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Myeloproliferative Disorders|Oligodendroglioma|Papillary Carcinoma|Pinealoma|Primitive Neuroectodermal Tumors|Rhabdoid Tumor
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| iEuroEwing | P3 |
Recruiting |
Sarcoma, Ewing |
2031-05-31 |
|
| cHOD17 | P2 |
Recruiting |
Hodgkin Lymphoma |
2027-01-01 |
|
| IRB-60439 | P1 |
Recruiting |
Acute Myeloid Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Myeloproliferative Disorders|Chronic Myeloid Leukemia|Myelodysplastic Syndrome |
2025-12-01 |
|
| MUKnineb | P2 |
Active, not recruiting |
Multiple Myeloma |
2025-10-01 |