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Blincyto(blinatumomab)
Blincyto (blinatumomab) is an antibody pharmaceutical. Blinatumomab was first approved as Blincyto on 2014-12-03. It is used to treat lymphoid leukemia in the USA. It has been approved in Europe to treat precursor cell lymphoblastic leukemia-lymphoma. It is known to target B-lymphocyte antigen CD19 and T-cell surface glycoprotein CD3 epsilon chain.
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Drugs Approved for Childhood Cancers
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Blincyto
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)
Blinatumomab
Tradename
Proper name
Company
Number
Date
Products
BlincytoblinatumomabAmgenN-125557 RX2014-12-03
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
blincytoBiologic Licensing Application2021-03-17
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
lymphoid leukemia—D007945C91
Agency Specific
FDA
EMA
Expiration
Code
blinatumomab, Blincyto, Amgen Inc.
2025-03-29Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FX: Other monoclonal antibodies and antibody drug conjugates in atc
— L01FX07: Blinatumomab
HCPCS
Code
Description
J9039
Injection, blinatumomab, 1 microgram
Clinical
Clinical Trials
91 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.083111—246
Philadelphia chromosomeD010677271——8
Hodgkin diseaseD006689C81131——3
Down syndromeD004314EFO_0001064Q90—11——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor t-cell lymphoblastic leukemia-lymphomaD05421827———8
Non-hodgkin lymphomaD008228C85.943———7
Residual neoplasmD01836513———4
Biphenotypic leukemia acuteD015456C95.013———3
Myeloid leukemia acuteD015470C92.0—3———3
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_000034012———3
Large b-cell lymphoma diffuseD016403C83.321———3
T-cell leukemiaD015458—2———2
Myelodysplastic syndromesD009190D46—2———2
Myelomonocytic leukemia juvenileD054429C93.3—2———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell lymphomaD0163932————2
Precursor b-cell lymphoblastic leukemia-lymphomaD0154521————1
B-cell leukemiaD0154481————1
Multiple myelomaD009101C90.01————1
Follicular lymphomaD008224C821————1
Mantle-cell lymphomaD020522C83.11————1
Myeloid leukemiaD007951C921————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBLINATUMOMAB
INNblinatumomab
Description
Blinatumumab (human BiTE)
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID853426-35-4
RxCUI1597258
ChEMBL IDCHEMBL1742992
ChEBI ID—
PubChem CID—
DrugBankDB09052
UNII ID4FR53SIF3A (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CD19
CD19
CD3E
CD3E
Organism
Homo sapiens
Gene name
CD19
Gene synonyms
NCBI Gene ID
930
Protein name
B-lymphocyte antigen CD19
Protein synonyms
B-lymphocyte surface antigen B4, CD19, Differentiation antigen CD19, T-cell surface antigen Leu-12
Uniprot ID
P15391
Mouse ortholog
Cd19 (12478)
B-lymphocyte antigen CD19 (Q542B2)
Variants
Clinical Variant
No data
Financial
Blincyto - Amgen
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,721 documents
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Safety
Black-box Warning
Black-box warning for: Blincyto
Adverse Events
Top Adverse Reactions
Mock data
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3,533 adverse events reported
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