Pegaspargase - PharmaKB

Oncaspar(pegaspargase)

Oncaspar (pegaspargase) is an enzyme pharmaceutical. Pegaspargase was first approved as Oncaspar on 1994-02-01. It is used to treat b-cell chronic lymphocytic leukemia, blast crisis, non-hodgkin lymphoma, and precursor cell lymphoblastic leukemia-lymphoma in the USA. It has been approved in Europe to treat precursor cell lymphoblastic leukemia-lymphoma.

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Clinical

Drug

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Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
hemic and lymphatic diseases	D006425
immune system diseases	D007154
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Oncaspar

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable product - 351(k)

Biosimilar product - 351(k)

Pegaspargase

Tradename	Proper name	Company	Number	Date	Products
Oncaspar	pegaspargase	Servier	N-103411 RX	1994-02-01	1 products

Labels

FDA

EMA

Brand Name	Status	Last Update
lyophilized pegaspargase	Export only	2020-08-03
oncaspar	Biologic Licensing Application	2024-03-05

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
non-hodgkin lymphoma	—	D008228	C85.9
precursor cell lymphoblastic leukemia-lymphoma	—	D054198	—
b-cell chronic lymphocytic leukemia	—	D015451	C91.1
blast crisis	—	D001752	—

Agency Specific

FDA

EMA

Expiration	Code
pegaspargase, Oncaspar, Servier Pharmaceuticals LLC
2101-02-01	Orphan excl.

Patent Expiration

No data

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01X: Other antineoplastic agents in atc

— L01XX: Other antineoplastic agents in atc

— L01XX24: Pegaspargase

HCPCS

Code	Description
J9266	Injection, pegaspargase, per single dose vial

Clinical

Clinical Trials

218 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	—	33	74	50	3	17	159
Leukemia	D007938	—	C95	32	69	47	3	14	148
Lymphoid leukemia	D007945	—	C91	29	63	40	3	13	134
Lymphoma	D008223	—	C85.9	10	53	18	3	8	87
T-cell lymphoma	D016399	—	—	6	25	6	3	7	45
T-cell lymphoma peripheral	D016411	—	—	4	24	6	2	7	41
Extranodal nk-t-cell lymphoma	D054391	—	C86.0	1	19	4	1	5	29
Syndrome	D013577	—	—	2	—	1	1	—	4
Hematologic neoplasms	D019337	—	—	1	1	—	1	—	3
Hemophagocytic lymphohistiocytosis	D051359	—	D76.1	—	—	2	1	—	3

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-hodgkin lymphoma	D008228	—	C85.9	5	16	7	—	—	26
Precursor t-cell lymphoblastic leukemia-lymphoma	D054218	—	—	5	7	5	—	—	15
Recurrence	D012008	—	—	3	6	1	—	—	9
Philadelphia chromosome	D010677	—	—	2	3	3	—	—	7
Acute disease	D000208	—	—	4	2	1	—	—	7
T-cell leukemia	D015458	—	—	2	3	2	—	—	5
Down syndrome	D004314	EFO_0001064	Q90	—	1	2	—	—	3
Central nervous system neoplasms	D016543	—	—	—	—	2	—	—	2
B-cell leukemia	D015448	—	—	—	2	1	—	—	2
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	—	1	—	—	1

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myeloid leukemia acute	D015470	—	C92.0	3	3	—	—	—	6
Biphenotypic leukemia acute	D015456	—	C95.0	—	3	—	—	—	3
Precursor b-cell lymphoblastic leukemia-lymphoma	D015452	—	—	1	3	—	—	—	3
Neoplasms	D009369	—	C80	1	2	—	—	—	3
Hypersensitivity	D006967	HP_0012393	T78.40	—	2	—	—	1	3
Myeloid leukemia	D007951	—	C92	—	2	—	—	—	2
Treatment refusal	D016312	—	—	—	2	—	—	—	2
Residual neoplasm	D018365	—	—	—	1	—	—	1	2
Inborn genetic diseases	D030342	EFO_0000508	—	—	1	—	—	—	1
Multiple myeloma	D009101	—	C90.0	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pancreatic neoplasms	D010190	EFO_0003860	C25	1	—	—	—	—	1
Adenocarcinoma	D000230	—	—	1	—	—	—	—	1
Myelodysplastic syndromes	D009190	—	D46	1	—	—	—	—	1
Preleukemia	D011289	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hyperlipidemias	D006949	HP_0003077	E78.5	—	—	—	—	1	1
Pancreatitis	D010195	HP_0001733	K85	—	—	—	—	1	1
Hyperlipoproteinemias	D006951	HP_0010980	—	—	—	—	—	1	1
Eye abnormalities	D005124	HP_0000478	Q15.9	—	—	—	—	1	1
Diabetes mellitus	D003920	HP_0000819	E08-E13	—	—	—	—	1	1
Glucose intolerance	D018149	HP_0000833	R73.03	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Pegaspargase
INN	pegaspargase
Description	Pegaspargase, sold under the brand name Oncaspar, is a medication used in the treatment of acute lymphoblastic leukemia (ALL). Often it is used together with anthracycline, vincristine, and corticosteroids (for example prednisone and dexamethasone). Pegaspargase can be administered either via an intravenous infusion or a intramuscular injection.
Classification	Enzyme
Drug class	enzymes; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	—