Epkinly, Tepkinly(epcoritamab)
Epkinly, Tepkinly (epcoritamab) is an antibody pharmaceutical. Epcoritamab was first approved as Epkinly on 2023-05-19. 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 T-cell surface glycoprotein CD3 epsilon chain and B-lymphocyte antigen CD20.
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YTD
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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 |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Epkinly
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| epcoritamab | Biologic Licensing Application | 2023-05-16 |
| epkinly | Biologic Licensing Application | 2024-07-26 |
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
36 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 |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 7 | 21 | 5 | — | 2 | 29 |
| B-cell lymphoma | D016393 | — | — | 7 | 13 | 3 | — | 1 | 18 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 5 | 11 | 3 | — | 1 | 16 |
| Follicular lymphoma | D008224 | — | C82 | 4 | 12 | 2 | — | 1 | 15 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 6 | 11 | — | — | — | 13 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 5 | 4 | — | — | — | 5 |
| Syndrome | D013577 | — | — | 3 | 1 | — | — | — | 3 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 3 | 3 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | 1 | 2 | — | — | — | 3 |
| Recurrence | D012008 | — | — | 2 | 2 | — | — | — | 3 |
| Leukemia | D007938 | — | C95 | 2 | 1 | — | — | — | 2 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 2 | 1 | — | — | — | 2 |
| Lymphoid leukemia | D007945 | — | C91 | 2 | 1 | — | — | — | 2 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aggression | D000374 | EFO_0003015 | — | 1 | — | — | — | — | 1 |
| Cytokine release syndrome | D000080424 | — | D89.83 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Epcoritamab |
| INN | epcoritamab |
| Description | Epcoritamab, sold under the brand name Epkinly, is a monoclonal antibody anticancer medication used for the treatment of diffuse large B-cell lymphoma. Epcoritamab is a bispecific CD20-directed CD3 T-cell engager. Epcoritamab was co-developed by AbbVie and Genmab.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 2134641-34-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4650393 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16672 |
| UNII ID | D6OMY2L0WA (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CD3E
CD3E
MS4A1
MS4A1
Organism
Homo sapiens
Gene name
CD3E
Gene synonyms
T3E
NCBI Gene ID
Protein name
T-cell surface glycoprotein CD3 epsilon chain
Protein synonyms
CD3-epsilon, CD3e, CD3e antigen, epsilon polypeptide (TiT3 complex), CD3e molecule, epsilon (CD3-TCR complex), T-cell antigen receptor complex, epsilon subunit of T3, T-cell surface antigen T3/Leu-4 epsilon chain
Uniprot ID
Mouse ortholog
Cd3e (12501)
T-cell surface glycoprotein CD3 epsilon chain (P22646)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Epkinly – AbbVie
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 389 documents
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Safety
Black-box Warning
Black-box warning for: Epcoritamab, Epkinly
Adverse Events
Top Adverse Reactions
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1,480 adverse events reported
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