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Drug ReportsPegaspargase
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
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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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
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Oncaspar
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Pegaspargase
Tradename
Proper name
Company
Number
Date
Products
OncasparpegaspargaseServierN-103411 RX1994-02-01
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
lyophilized pegaspargaseExport only2020-08-03
oncasparBiologic Licensing Application2024-10-07
Agency Specific
FDA
EMA
Expiration
Code
pegaspargase, Oncaspar, Servier Pharmaceuticals LLC
2101-02-01Orphan 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-lymphomaD054198——337450317159
LeukemiaD007938—C95326947314148
Lymphoid leukemiaD007945—C91296340313134
LymphomaD008223—C85.91053183887
T-cell lymphomaD016399——62563745
T-cell lymphoma peripheralD016411——42462741
Extranodal nk-t-cell lymphomaD054391—C86.011941529
SyndromeD013577——2—11—4
Hematologic neoplasmsD019337——11—1—3
Hemophagocytic lymphohistiocytosisD051359—D76.1——21—3
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.95167——26
Precursor t-cell lymphoblastic leukemia-lymphomaD054218——575——15
RecurrenceD012008——361——9
Philadelphia chromosomeD010677——233——7
Acute diseaseD000208——421——7
T-cell leukemiaD015458——232——5
Down syndromeD004314EFO_0001064Q90—12——3
Central nervous system neoplasmsD016543————2——2
B-cell leukemiaD015448———21——2
Drug-related side effects and adverse reactionsD064420—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 acuteD015470—C92.033———6
Biphenotypic leukemia acuteD015456—C95.0—3———3
Precursor b-cell lymphoblastic leukemia-lymphomaD015452——13———3
NeoplasmsD009369—C8012———3
HypersensitivityD006967HP_0012393T78.40—2——13
Myeloid leukemiaD007951—C92—2———2
Treatment refusalD016312———2———2
Residual neoplasmD018365———1——12
Inborn genetic diseasesD030342EFO_0000508——1———1
Multiple myelomaD009101—C90.0—1———1
Show 9 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C251————1
AdenocarcinomaD000230——1————1
Myelodysplastic syndromesD009190—D461————1
PreleukemiaD011289——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperlipidemiasD006949HP_0003077E78.5————11
PancreatitisD010195HP_0001733K85————11
HyperlipoproteinemiasD006951HP_0010980—————11
Eye abnormalitiesD005124HP_0000478Q15.9————11
Diabetes mellitusD003920HP_0000819E08-E13————11
Glucose intoleranceD018149HP_0000833R73.03————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePegaspargase
INNpegaspargase
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 classenzymes; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2108546
ChEBI ID—
PubChem CID—
DrugBankDB00059
UNII ID7D96IR0PPM (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,508 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,957 adverse events reported
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