Drug · Other

Pegfilgrastim

CI-DRUG-00000706Explore in graph →CHEMBL1201568 Approved

Regulatory

Approvals (27)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. • Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). • Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.	approved	May 26, 2022	openfda
US FDA	—	Efficacy supplement 2015-11-13 (see label)	approved	Nov 13, 2015	openfda
US FDA	—	Efficacy supplement 2005-09-15 (see label)	approved	Sep 15, 2005	openfda
US FDA	—	Neulasta is a leukocyte growth factor indicated in adult and pediatric patients to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. • Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). • Limitations of Use Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 21 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	34	19	44	220	27	CA, EU, US	Jan 31, 2002	1999-09
Non-Hodgkin Lymphoma	Phase4	Phase 4	9	4	4	34	0	—	—	2002-06
Malignant Breast Neoplasm	Phase4	Phase 4	5	2	13	52	0	—	—	2001-10
Malignant Lung Neoplasm	Phase4	Phase 4	2	1	1	14	0	—

Curated evidence

Clinical evidence (0)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

Data not yet available

No curated evidence item mentions this therapy yet.

Clinical trials

Trials with this intervention (223)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 151–200 of 223 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT01682044	Pegfilgrastim and Rituximab in Treating Patients With Untreated, Relapsed, or Refractory Follicular Lymphoma, Small Lymphocytic Lymphoma, or Marginal Zone Lymphoma	completed	Phase 2	20	Roswell Park Cancer InstituteOTHER	1	Oct 9, 2017	clinicaltrials
NCT00151242	Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

Molecule

Record

Kind: Other
Mechanism: Granulocyte colony stimulating factor receptor agonist
Targets: 1 gene
UNII: 3A58010674
Aliases: ARMLUPEG, B-12019, B12019, Cegfila, Cegfila (previously pegfilgrastim mundipharma), Chs-1701, DYRUPEG, Fulphila, FULPHILA, Fylnetra, FYLNETRA, Granulocyte colony-stimulating factor pegfilgrastim, Grasustek, Hsp-130, La-ep2006, LA EP 2006, LAPELGA, Lupifil-p, Msb-11455, Msb11455, MYL-1401H, NEULASTA, Neulasta sureclick, Neupopeg, NIOPEG, Nyvepria, NYVEPRIA, Peg-filgrastim, Pegfilgrastim, Pegfilgrastim apgf … (+25)

Data updated 2 days agoSource updated unknown

Identifiers

Codes (34)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L03AA13	PEGFILGRASTIM
DIN (Health Canada)	02249790