Pegfilgrastim - PharmaKB

Neulasta(pegfilgrastim)

Cegfila, Fulphila, Fylnetra, Grasustek, Neulasta, Nyvepria, Pegfilgrastim, Pelgraz, Pelmeg, Stimufend, Udenyca, Ziextenzo (pegfilgrastim) is a protein pharmaceutical. Pegfilgrastim was first approved as Neulasta on 2002-01-31. It is used to treat neutropenia in the USA. It has been approved in Europe to treat neoplasms and neutropenia. The pharmaceutical is active against granulocyte colony-stimulating factor receptor.

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Clinical

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Events Timeline

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
hemic and lymphatic diseases	D006425

Trade Name

FDA

EMA

Fulphila, Fylnetra, Neulasta onpro, Nyvepria, Stimufend, Udenyca onbody, Ziextenzo

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable product - 351(k)

Biosimilar product - 351(k)

Pegfilgrastim

Tradename	Proper name	Company	Number	Date	Products
Neulasta	pegfilgrastim	Amgen	N-125031 RX	2002-01-31	1 products
Neulasta Onpro	pegfilgrastim	Amgen	N-125031 RX	2014-12-23	1 products

Labels

FDA

EMA

Brand Name	Status	Last Update
fulphila	Biologic Licensing Application	2023-12-05
fylnetra	Biologic Licensing Application	2022-05-31
neulasta	Biologic Licensing Application	2024-10-31
nyvepria	Biologic Licensing Application	2023-06-29
stimufend	Biologic Licensing Application	2023-10-24
udenyca	Biologic Licensing Application	2024-08-20
ziextenzo	Biologic Licensing Application	2022-12-14

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
neutropenia	—	D009503	D70

Agency Specific

FDA

EMA

Expiration	Code
pegfilgrastim, Neulasta, Amgen Inc.
2122-11-13	Orphan excl.
pegfilgrastim, Neulasta Onpro, Amgen Inc.
2122-11-13	Orphan excl.

Patent Expiration

No data

ATC Codes

L: Antineoplastic and immunomodulating agents

— L03: Immunostimulants

— L03A: Immunostimulants

— L03AA: Colony stimulating factors

— L03AA13: Pegfilgrastim

HCPCS

Code	Description
J2506	Injection, pegfilgrastim, excludes biosimilar, 0.5 mg
Q5108	Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg
Q5111	Injection, pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg
Q5120	Injection, pegfilgrastim-bmez, biosimilar, (ziextenzo), 0.5 mg
Q5122	Injection, pegfilgrastim-apgf, biosimilar, (nyvepria), 0.5 mg

Clinical

Clinical Trials

443 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Breast neoplasms	D001943	EFO_0003869	C50	11	51	25	11	11	102
Lymphoma	D008223	—	C85.9	24	63	15	4	5	96
Neutropenia	D009503	—	D70	7	19	23	8	8	62
Non-hodgkin lymphoma	D008228	—	C85.9	12	23	2	3	4	37
B-cell lymphoma	D016393	—	—	9	17	7	1	1	31
Neoplasms	D009369	—	C80	10	12	4	1	2	28
Large b-cell lymphoma diffuse	D016403	—	C83.3	10	15	4	1	1	25
Lung neoplasms	D008175	—	C34.90	2	9	2	2	3	18
Chemotherapy-induced febrile neutropenia	D064146	—	—	—	5	9	1	4	18
Non-small-cell lung carcinoma	D002289	—	—	2	10	2	1	1	16

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Leukemia	D007938	—	C95	6	30	10	—	2	39
Lymphoid leukemia	D007945	—	C91	4	20	6	—	1	26
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	3	15	6	—	1	21
Multiple myeloma	D009101	—	C90.0	3	13	3	—	2	19
Plasma cell neoplasms	D054219	—	—	3	12	3	—	2	18
Sarcoma	D012509	—	—	5	11	2	—	2	17
Carcinoma	D002277	—	C80.0	3	10	2	—	1	16
Recurrence	D012008	—	—	5	10	2	—	—	15
Hodgkin disease	D006689	—	C81	4	7	5	—	—	13
Myeloid leukemia acute	D015470	—	C92.0	1	8	4	—	—	11

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	2	8	—	—	—	8
Pancreatic neoplasms	D010190	EFO_0003860	C25	5	2	—	—	1	8
Prostatic neoplasms	D011471	—	C61	4	5	—	—	—	7
Transitional cell carcinoma	D002295	—	—	—	6	—	—	1	7
Mantle-cell lymphoma	D020522	—	C83.1	4	4	—	—	—	6
Ewing sarcoma	D012512	EFO_0000173	—	3	4	—	—	—	6
Central nervous system neoplasms	D016543	—	—	2	5	—	—	—	6
Head and neck neoplasms	D006258	—	—	3	3	—	—	—	5
Rhabdomyosarcoma	D012208	—	—	3	4	—	—	—	5
Follicular lymphoma	D008224	—	C82	3	3	—	—	—	5

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	17	—	—	—	1	18
Neuroblastoma	D009447	EFO_0000621	—	2	—	—	—	2	4
Coronary artery disease	D003324	—	I25.1	1	—	—	—	1	2
Myocardial ischemia	D017202	EFO_1001375	I20-I25	1	—	—	—	1	2
Therapeutic equivalency	D013810	—	—	2	—	—	—	—	2
Pharmacokinetics	D010599	—	—	2	—	—	—	—	2
Neoplasm metastasis	D009362	EFO_0009708	—	2	—	—	—	—	2
Brain neoplasms	D001932	EFO_0003833	C71	1	—	—	—	—	1
T-cell lymphoma cutaneous	D016410	—	C84.A	1	—	—	—	—	1
Vaccine immunogenicity	D000071497	—	—	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pheochromocytoma	D010673	—	—	—	—	—	—	2	2
Hemophagocytic lymphohistiocytosis	D051359	—	D76.1	—	—	—	—	1	1
Coronary disease	D003327	—	—	—	—	—	—	1	1
Bone nails	D001858	—	—	—	—	—	—	1	1
Patient reported outcome measures	D000071066	—	—	—	—	—	—	1	1
Patient satisfaction	D017060	—	—	—	—	—	—	1	1
Patient preference	D057240	—	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Pegfilgrastim
INN	pegfilgrastim
Description	Granulocyte colony-stimulating factor precursor (G-CSF) (Pluripoietin)
Classification	Protein
Drug class	PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer; colony-stimulating factors: granulocyte colony-stimulating factors (G-CSF)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	—