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Drug ReportsEpcoritamab
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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Variants
Financial
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Events Timeline
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6M
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
Epkinly
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)
Epcoritamab
Tradename
Proper name
Company
Number
Date
Products
Epkinlyepcoritamab-byspGenmabN-761324 RX2023-05-19
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
epcoritamabBiologic Licensing Application2023-05-16
epkinlyBiologic Licensing Application2024-07-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
large b-cell lymphoma diffuse—D016403C83.3
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
LymphomaD008223—C85.97215—229
B-cell lymphomaD016393——7133—118
Large b-cell lymphoma diffuseD016403—C83.35113—116
Follicular lymphomaD008224—C824122—115
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.9611———13
B-cell chronic lymphocytic leukemiaD015451—C91.154———5
SyndromeD013577——31———3
B-cell lymphoma marginal zoneD018442—C88.433———3
NeoplasmsD009369—C8012———3
RecurrenceD012008——22———3
LeukemiaD007938—C9521———2
Reactive arthritisD016918EFO_0007460M02.321———2
Lymphoid leukemiaD007945—C9121———2
Lymphoproliferative disordersD008232Orphanet_2442D47.911———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AggressionD000374EFO_0003015—1————1
Cytokine release syndromeD000080424—D89.831————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEpcoritamab
INNepcoritamab
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 classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID2134641-34-0
RxCUI—
ChEMBL IDCHEMBL4650393
ChEBI ID—
PubChem CID—
DrugBankDB16672
UNII IDD6OMY2L0WA (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
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 405 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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