epcoritamab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
rat origin 5734 2134641-34-0

Description:

MoleculeDescription

Molfile

Synonyms:

  • epcoritamab
  • epcoritamab-bysp
  • GEN3013
  • epkinly
Epcoritamab-bysp is a T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and healthy B-lineage cells. In vitro, epcoritamab-bysp activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
May 19, 2023 FDA GENMAB US, INC.
Sept. 22, 2023 EMA AbbVie Deutschland GmbH & Co. KG

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cytokine release syndrome 1905.10 44.82 371 2425 27602 90598049
Immune effector cell-associated neurotoxicity syndrome 337.32 44.82 68 2728 5700 90619951
Febrile neutropenia 217.63 44.82 103 2693 158246 90467405
Pyrexia 109.57 44.82 117 2679 660368 89965283
Hydronephrosis 105.79 44.82 31 2765 12371 90613280
Cytomegalovirus infection 89.91 44.82 33 2763 26569 90599082
Tumour pseudoprogression 76.28 44.82 14 2782 707 90624944
Sepsis 74.86 44.82 54 2742 179760 90445891
Cytomegalovirus infection reactivation 73.17 44.82 21 2775 7779 90617872
Cytomegalovirus test positive 63.72 44.82 16 2780 3575 90622076
Hypogammaglobulinaemia 62.53 44.82 20 2776 10654 90614997
COVID-19 pneumonia 55.72 44.82 21 2775 18156 90607495
Neutrophil count decreased 48.03 44.82 29 2767 71503 90554148
COVID-19 46.97 44.82 40 2756 168803 90456848
Blood creatinine increased 45.69 44.82 32 2764 101354 90524297

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cytokine release syndrome 2013.38 35.66 515 3407 44012 42573401
Immune effector cell-associated neurotoxicity syndrome 320.05 35.66 88 3834 9373 42608040
Pyrexia 164.04 35.66 190 3732 393852 42223561
Febrile neutropenia 124.51 35.66 116 3806 185587 42431826
COVID-19 100.69 35.66 84 3838 115864 42501549
Cytomegalovirus infection reactivation 79.15 35.66 32 3890 11146 42606267
C-reactive protein increased 78.96 35.66 57 3865 63503 42553910
Fibrin D dimer increased 71.51 35.66 24 3898 4961 42612452
Diffuse large B-cell lymphoma 63.28 35.66 26 3896 9428 42607985
Septic shock 56.83 35.66 55 3867 91617 42525796
COVID-19 pneumonia 56.24 35.66 31 3891 21582 42595831
Hypogammaglobulinaemia 51.27 35.66 24 3898 11867 42605546
Pneumocystis jirovecii infection 50.02 35.66 16 3906 2844 42614569
Sepsis 45.17 35.66 72 3850 199262 42418151
Pneumonia 44.00 35.66 110 3812 422039 42195374
Neutropenic infection 43.39 35.66 13 3909 1860 42615553
Neutrophil count decreased 42.98 35.66 40 3882 63375 42554038
Enterobacter pneumonia 42.73 35.66 10 3912 551 42616862
Tumour lysis syndrome 42.22 35.66 26 3896 22205 42595208
Disease progression 41.25 35.66 58 3864 143598 42473815
Tumour pseudoprogression 36.51 35.66 10 3912 1040 42616373
Abdominal mass 36.25 35.66 12 3910 2374 42615039

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cytokine release syndrome 3857.63 42.27 877 5832 69429 110513161
Immune effector cell-associated neurotoxicity syndrome 569.43 42.27 140 6569 14642 110567948
Febrile neutropenia 331.20 42.27 217 6492 316550 110266040
Pyrexia 283.08 42.27 307 6402 897958 109684632
COVID-19 199.10 42.27 144 6565 244916 110337674
Cytomegalovirus infection reactivation 153.10 42.27 53 6656 18280 110564310
Hypogammaglobulinaemia 118.79 42.27 45 6664 20031 110562559
Sepsis 118.29 42.27 121 6588 327225 110255365
COVID-19 pneumonia 110.52 42.27 51 6658 37092 110545498
Cytomegalovirus infection 106.02 42.27 56 6653 54388 110528202
Diffuse large B-cell lymphoma 95.37 42.27 36 6673 15862 110566728
Neutrophil count decreased 93.26 42.27 69 6640 120872 110461718
Tumour pseudoprogression 86.49 42.27 20 6689 1596 110580994
Neutropenic infection 81.99 42.27 22 6687 3223 110579367
Tumour lysis syndrome 81.47 42.27 39 6670 30762 110551828
Cytomegalovirus test positive 81.32 42.27 26 6683 7010 110575580
C-reactive protein increased 77.58 42.27 80 6629 217839 110364751
Hydronephrosis 72.99 42.27 32 6677 20633 110561957
Pneumonia 70.27 42.27 160 6549 876554 109706036
Septic shock 69.40 42.27 65 6644 157463 110425127
Fibrin D dimer increased 65.28 42.27 24 6685 9821 110572769
Neutropenia 64.00 42.27 95 6614 374525 110208065
Haemophagocytic lymphohistiocytosis 62.94 42.27 33 6676 31526 110551064
Pneumocystis jirovecii infection 58.09 42.27 18 6691 4382 110578208
Tumour associated fever 54.92 42.27 13 6696 1148 110581442
Hypoxia 48.67 42.27 49 6660 129466 110453124
Thrombocytopenia 43.84 42.27 77 6632 348808 110233782
Cytomegalovirus viraemia 42.47 42.27 21 6688 17743 110564847

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FX27 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Other monoclonal antibodies and antibody drug conjugates
FDA PE N0000009267 Increased Cytokine Activity
FDA MoA N0000175078 CD20-directed Antibody Interactions
MeSH PA D000074322 Antineoplastic Agents, Immunological
MeSH PA D000970 Antineoplastic Agents
FDA MoA N0000175617 CD3-directed Antibody Interactions
FDA MoA N0000175618 CD3 Receptor Agonists
FDA MoA N0000182136 Cytochrome P450 Inhibitors
FDA EPC N0000194063 Bispecific CD20-directed CD3 T Cell Engager
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

L01FX Other monoclonal antibodies and antibody drug conjugates 29 drugs
amivantamabbelantamab mafodotinblinatumomabbrentuximab vedotincatumaxomabdatopotamab deruxtecanelotuzumabelranatamabenfortumab vedotingemtuzumab ozogamicinglofitamabipilimumab show all 29 →

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Relapsed or refractory diffuse large B-cell lymphoma indication 1172695008




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
T-cell surface glycoprotein CD3 Surface antigen ANTIBODY BINDING EC50 8.80 DRUG LABEL DRUG LABEL
B-lymphocyte antigen CD20 Surface antigen ANTIBODY BINDING EC50 8.61 DRUG LABEL DRUG LABEL

External reference:

IDSource
CHEBI:758284 CHEBI
CHEMBL4650393 ChEMBL_ID
C000731938 MESH_SUPPLEMENTAL_RECORD_UI
11442 IUPHAR_LIGAND_ID
DB16672 DRUGBANK_ID
1363209009 SNOMEDCT_US
4042278 VANDF
4042279 VANDF
C5418281 UMLSCUI
11078 INN_ID
367260 MMSL
41558 MMSL
d10049 MMSL
019447 NDDF
D12368 KEGG_DRUG
D6OMY2L0WA UNII
2637392 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
EPKINLY HUMAN PRESCRIPTION DRUG LABEL 1 82705-002 INJECTION, SOLUTION 4 mg SUBCUTANEOUS BLA 32 sections
EPKINLY HUMAN PRESCRIPTION DRUG LABEL 1 82705-010 INJECTION, SOLUTION 48 mg SUBCUTANEOUS BLA 32 sections