Zevalin(ibritumomab tiuxetan)
Zevalin (ibritumomab tiuxetan) is an antibody drug conjugate 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 |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
| immune system diseases | D007154 |
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 |
|---|---|---|---|---|---|
| Zevalin | ibritumomab tiuxetan | Acrotech Biopharma | N-125019 RX | 2002-02-19 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zevalin | Biologic Licensing Application | 2023-04-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| follicular lymphoma | — | D008224 | C82 |
| b-cell lymphoma | — | D016393 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ibritumomab tiuxetan, Zevalin, Acrotech Biopharma Inc. | |||
| 2109-02-19 | Orphan excl. | ||
Patent Expiration
No data
Clinical
Clinical Trials
107 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Follicular lymphoma | D008224 | — | C82 | 7 | 19 | 8 | — | 1 | 31 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 4 | 20 | 3 | — | — | 24 |
| B-cell lymphoma | D016393 | — | — | 3 | 12 | 2 | — | 1 | 16 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mantle-cell lymphoma | D020522 | — | C83.1 | 4 | 12 | — | — | — | 14 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 6 | 7 | — | — | 1 | 11 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 5 | 9 | — | — | — | 11 |
| Waldenstrom macroglobulinemia | D008258 | — | C88.0 | 5 | 6 | — | — | — | 8 |
| Burkitt lymphoma | D002051 | — | C83.7 | 3 | 4 | — | — | — | 5 |
| Leukemia | D007938 | — | C95 | 1 | 3 | — | — | 1 | 4 |
| Large-cell lymphoma immunoblastic | D016400 | — | — | 1 | 4 | — | — | — | 4 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 1 | — | — | 1 | 3 |
| Plasma cell neoplasms | D054219 | — | — | 1 | 1 | — | — | 1 | 3 |
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | — | 3 | — | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | 2 | — | — | — | — | 2 |
| Plasmacytoma | D010954 | — | C90.3 | 1 | — | — | — | — | 1 |
| Interdigitating dendritic cell sarcoma | D054739 | — | C96.4 | 1 | — | — | — | — | 1 |
| Bone marrow transplantation | D016026 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoid leukemia | D007945 | — | C91 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ibritumomab tiuxetan |
| INN | ibritumomab tiuxetan |
| Description | Immunoglobulin G1, anti-(human CD20 (antigen)) (mouse monoclonal IDECÂY2B8 71-chain), disulfide with mouse monoclonal IDEC-Y2B8 x-chain, dimer, iV-[2-[bis(carboxymethyl)amino]-3-(4-isothiocyanatophenyl) propyl]ÂiV-[2-[bis(carboxymethyl) amino]propyl]glycine conjugate |
| Classification | Antibody |
| Drug class | monoclonal antibodies; chelating agents |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 206181-63-7 |
| RxCUI | 262323 |
| ChEMBL ID | CHEMBL1201606 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00078 |
| UNII ID | 4Q52C550XK (ChemIDplus, GSRS) |
Target
Agency Approved
MS4A1
MS4A1
Organism
Homo sapiens
Gene name
MS4A1
Gene synonyms
CD20
NCBI Gene ID
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
Mouse ortholog
Ms4a1 (12482)
B-lymphocyte antigen CD20 (P19437)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Zevalin – Spectrum Pharmaceuticals
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,612 documents
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Safety
Black-box Warning
Black-box warning for: Zevalin
Adverse Events
Top Adverse Reactions
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2,063 adverse events reported
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