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Drug

Filgrastim

Established medicine
ResearchOngoing research
Also known as Filgrastim (E. coli), Granix, Neupogen, Nivestym+5 more

Filgrastim (E. coli), Granix, Neupogen, Nivestym, Nypozi, Releuko, Zarxio, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor.

RxNorm68442UNIIPVI5M0M1GW
1
Research papers
25
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase III Trial (NRG Oncology/GOG0209).

Research2020-09-29Miller DS · Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Filgrastim
Aliases & brands
Filgrastim (E. coli)GranixNeupogenNivestymNypoziReleukoZarxior-metHuG-CSFRecombinant Methionyl Human Granulocyte Colony Stimulating Factor
RxNorm CUI
68442
UNII
PVI5M0M1GW
Regulatory jurisdictions
fdaema

Regulatory timeline

25 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1991-02-20
Latest approval
2015-03-30
Authorities
FDA · EMA
Total events
25
fdaU.S. Food and Drug Administration· 24 events
2026-07-16Label change
Label change: FILGRASTIM (BLA103353)
Evidence ↗
2025-04-18Label change
Label change: FILGRASTIM (BLA103353)
Evidence ↗
2023-04-18Label change
Label change: FILGRASTIM (BLA103353)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2010-06-07Approval
Approval: Nivestim (EMA)
Indication: Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy forShow full indication

Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ?0.5 x 109/l and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Filgrastim is indicated for the treatment of persistent neutropenia (ANC ?1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase III Trial (NRG Oncology/GOG0209).

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020 · 235 cites
Recent papers

Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase III Trial (NRG Oncology/GOG0209).

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020 · 235 cites
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Argenta PA1
  • Carney ME1
  • Cella D1
  • Cohn DE1
  • DiSilvestro P1
  • Filiaci VL1
  • Fleming GF1
  • Hanjani P1
Leading institutions
free-text, unnormalised
  • Arthur G. James Cancer Hospital and Solove Research Institute1
  • Clinical Trial Development Division1
  • Cooper Hospital/University Medical Center1
  • Ehime University School of Medicine1
  • Hanjani Institute for Gynecologic Oncology1
  • John A. Burns School of Medicine1

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across the same disease area as Filgrastim in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Filgrastim in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Filgrastim in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • Regulatory event sources are credited in the Regulatory Timeline above.