Columvi(glofitamab)
Columvi (glofitamab) is an antibody pharmaceutical. Glofitamab was first approved as Columvi on 2023-06-15. It is used to treat large b-cell lymphoma diffuse in the USA. It has been approved in Europe to treat large b-cell lymphoma diffuse. It is known to target B-lymphocyte antigen CD20.
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
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Start date
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Completion date
Results first post date
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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
Columvi
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| columvi | Biologic Licensing Application | 2024-11-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| large b-cell lymphoma diffuse | — | D016403 | C83.3 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
52 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 20 | 31 | 3 | — | 4 | 49 |
| B-cell lymphoma | D016393 | — | — | 15 | 21 | 2 | — | 4 | 35 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 7 | 14 | 1 | — | 2 | 22 |
| Mantle-cell lymphoma | D020522 | — | — | 3 | 8 | 1 | — | — | 10 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 10 | 8 | — | — | 1 | 14 |
| Aggression | D000374 | EFO_0003015 | — | 1 | 1 | — | — | — | 2 |
| Recurrence | D012008 | — | — | — | 1 | — | — | 1 | 2 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | — | 1 | — | — | — | 1 |
| Follicular lymphoma | D008224 | — | C82 | — | 1 | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | — | 1 | — | — | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | — | 1 | — | — | — | 1 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Residual neoplasm | D018365 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hodgkin disease | D006689 | — | C81 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Glofitamab |
| INN | glofitamab |
| Description | Glofitamab, sold under the brand name Columvi, is a bispecific monoclonal antibody used for the treatment of large B-cell lymphoma. It is a bispecific CD20-directed CD3 T-cell engager.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 2229047-91-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4298092 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16371 |
| UNII ID | 06P3KLK2J8 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
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)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 488 documents
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Safety
Black-box Warning
Black-box warning for: Columvi
Adverse Events
Top Adverse Reactions
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591 adverse events reported
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