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Zevalin(ibritumomab tiuxetan)
Zevalin (ibritumomab tiuxetan) is an antibody pharmaceutical. Ibritumomab tiuxetan was first approved as Zevalin on 2002-02-19. It is used to treat b-cell lymphoma and follicular lymphoma in the USA. It has been approved in Europe to treat follicular lymphoma. The pharmaceutical is active against B-lymphocyte antigen CD20.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Zevalin
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)
Ibritumomab tiuxetan
Tradename
Proper name
Company
Number
Date
Products
Zevalinibritumomab tiuxetanAcrotech BiopharmaN-125019 RX2002-02-19
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
zevalinBiologic Licensing Application2019-09-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
b-cell lymphoma—D016393—
follicular lymphoma—D008224C82
Agency Specific
FDA
EMA
Expiration
Code
ibritumomab tiuxetan, Zevalin, Acrotech Biopharma Inc.
2109-02-19Orphan excl.
Patent Expiration
No data
ATC Codes
V: Various drug classes in atc
— V10: Therapeutic radiopharmaceuticals
— V10X: Other therapeutic radiopharmaceuticals in atc
— V10XX: Various therapeutic radiopharmaceuticals
— V10XX02: Ibritumomab tiuxetan (90y)
HCPCS
Code
Description
A9542
Indium in-111 ibritumomab tiuxetan, diagnostic, per study dose, up to 5 millicuries
A9543
Yttrium y-90 ibritumomab tiuxetan, therapeutic, per treatment dose, up to 40 millicuries
Clinical
Clinical Trials
97 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228C85.951761431
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Large b-cell lymphoma diffuseD016403C83.33143——18
Follicular lymphomaD008224C82385—115
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.91125——232
Mantle-cell lymphomaD020522C83.129———10
Waldenstrom macroglobulinemiaD008258C88.045———6
B-cell lymphoma marginal zoneD018442C88.434———5
B-cell chronic lymphocytic leukemiaD015451C91.133———4
Burkitt lymphomaD002051C83.713———3
B-cell lymphomaD01639312———3
LeukemiaD007938C9512———2
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.011———2
Large-cell lymphoma anaplasticD017728C84.6—2———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Plasma cell neoplasmsD0542191————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIBRITUMOMAB TIUXETAN
INNibritumomab tiuxetan
Description
Immunoglobulin G1, anti-(human CD20 (antigen)) (mouse monoclonal IDEC­Y2B8 71-chain), disulfide with mouse monoclonal IDEC-Y2B8 x-chain, dimer, iV-[2-[bis(carboxymethyl)amino]-3-(4-isothiocyanatophenyl) propyl]­iV-[2-[bis(carboxymethyl) amino]propyl]glycine conjugate
Classification
Antibody
Drug classmonoclonal antibodies; chelating agents
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID206181-63-7
RxCUI262323
ChEMBL IDCHEMBL1201606
ChEBI ID—
PubChem CID—
DrugBankDB00078
UNII ID4Q52C550XK (ChemIDplus, GSRS)
Target
Agency Approved
MS4A1
MS4A1
Organism
Homo sapiens
Gene name
MS4A1
Gene synonyms
CD20
NCBI Gene ID
931
Protein name
B-lymphocyte antigen CD20
Protein synonyms
B-lymphocyte cell-surface antigen B1, B-lymphocyte surface antigen B1, Bp35, CD20, CD20 antigen, CD20 receptor, Leukocyte surface antigen Leu-16, Membrane-spanning 4-domains subfamily A member 1, membrane-spanning 4-domains, subfamily A, member 1
Uniprot ID
Q13963
Mouse ortholog
Ms4a1 (12482)
B-lymphocyte antigen CD20 (P19437)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Zevalin - Spectrum Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,420 documents
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Safety
Black-box Warning
Black-box warning for: Zevalin
Adverse Events
Top Adverse Reactions
Mock data
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25,517 adverse events reported
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