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Drug ReportsBlinatumomab
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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Financial
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Events Timeline
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1M
3M
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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
Start date
Primary completion date
Completion date
Results first post date
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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 Application2024-12-19
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
132 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——2163182999
Lymphoid leukemiaD007945—C912263172897
LeukemiaD007938—C952165182596
Residual neoplasmD018365——19—1213
Precursor t-cell lymphoblastic leukemia-lymphomaD054218——59—1—13
Precursor b-cell lymphoblastic leukemia-lymphomaD015452——241117
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Philadelphia chromosomeD010677——4163—122
LymphomaD008223—C85.910103——19
B-cell lymphomaD016393——761——11
Non-hodgkin lymphomaD008228—C85.9651——10
RecurrenceD012008——421—17
Biphenotypic leukemia acuteD015456—C95.0141——4
Hodgkin diseaseD006689—C81131——3
Acute diseaseD000208——2—1——3
Down syndromeD004314EFO_0001064Q90—11——2
SyndromeD013577——1—1——2
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—26———8
Myeloid leukemiaD007951—C9224———6
Large b-cell lymphoma diffuseD016403—C83.333———6
Myeloid leukemia acuteD015470—C92.0—3———3
Hematologic neoplasmsD019337———3———3
B-cell chronic lymphocytic leukemiaD015451—C91.131———3
Blast crisisD001752——12———3
T-cell leukemiaD015458———2———2
Myelodysplastic syndromesD009190—D46—2———2
Myelomonocytic leukemia juvenileD054429—C93.3—2———2
Show 10 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell leukemiaD015448——1————1
Multiple myelomaD009101—C90.01————1
Plasma cell neoplasmsD054219——1————1
Mediastinal neoplasmsD008479—C38.31————1
B-cell lymphoma marginal zoneD018442—C88.41————1
Follicular lymphomaD008224—C821————1
Mantle-cell lymphomaD020522——1————1
NeoplasmsD009369—C801————1
Nephrotic syndromeD009404EFO_0004255N041————1
NephrosisD009401——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
High-throughput nucleotide sequencingD059014——————11
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)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1742992
ChEBI ID—
PubChem CID—
DrugBankDB09052
UNII ID4FR53SIF3A (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CD19
CD19
Organism
Homo sapiens
Gene name
CD19
Gene synonyms
NCBI Gene ID
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
Mouse ortholog
Cd19 (12478)
B-lymphocyte antigen CD19 (Q542B2)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Blincyto – Amgen
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,980 documents
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Safety
Black-box Warning
Black-box warning for: Blincyto
Adverse Events
Top Adverse Reactions
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8,192 adverse events reported
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