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

Stem definitionDrug idCAS RN
antitumor, monoclonal antibodies 5404 1422527-84-1

Description:

MoleculeDescription

Molfile

Synonyms:

  • tafasitamab
  • tafasitamab-cxix
  • monjuvi
  • MOR00208
  • MOR-00208
  • MOR 208
  • anti-CD19 MoAb XmAb5574
  • XmAb5574
  • XmAb-5574
  • XENP-5574
  • minjuvi
Tafasitamab-cxix is an Fc-modified monoclonal antibody that binds to CD19 antigen expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL). Upon binding to CD19, tafasitamab-cxix mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
  • 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
July 31, 2020 FDA MORPHOSYS US INC
Aug. 26, 2021 EMA INCYTE BIOSCIENCES DISTRIBUTION B.V.

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
Disease progression 448.85 67.08 146 1388 156469 90470444
Lymphoma 297.79 67.08 64 1470 13527 90613386
Off label use 114.06 67.08 114 1420 1102138 89524775
Neutropenia 91.18 67.08 53 1481 224851 90402062
Gastric cancer 72.87 67.08 17 1517 5119 90621794
Cytopenia 68.98 67.08 21 1513 17428 90609485
COVID-19 pneumonia 68.14 67.08 21 1513 18156 90608757

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
Disease progression 380.36 59.84 156 1457 143500 42476222
Lymphoma 373.18 59.84 90 1523 14231 42605491
Off label use 147.49 59.84 147 1466 638188 41981534
COVID-19 69.41 59.84 47 1566 115901 42503821
Malignant neoplasm progression 60.25 59.84 42 1571 108358 42511364

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
Disease progression 681.99 51.54 252 2749 243782 110342516
Off label use 252.04 51.54 250 2751 1499935 109086363
Lymphoma 208.89 51.54 57 2944 20114 110566184
Neutropenia 130.96 51.54 96 2905 374524 110211774
Cytokine release syndrome 96.29 51.54 44 2957 70262 110516036
COVID-19 85.84 51.54 63 2938 244997 110341301
Malignant neoplasm progression 85.02 51.54 55 2946 174512 110411786
Testicular disorder 58.82 51.54 10 2991 369 110585929
Blood lactate dehydrogenase increased 58.31 51.54 27 2974 44307 110541991
Cytopenia 58.02 51.54 24 2977 30092 110556206
Thrombocytopenia 56.99 51.54 58 2943 348827 110237471
Diffuse large B-cell lymphoma recurrent 56.84 51.54 16 2985 6283 110580015
COVID-19 pneumonia 56.38 51.54 25 2976 37118 110549180
Haematotoxicity 55.30 51.54 21 2980 21061 110565237
Hypogammaglobulinaemia 52.67 51.54 20 2981 20056 110566242
Febrile neutropenia 52.33 51.54 53 2948 316714 110269584
Follicular lymphoma 51.94 51.54 10 2991 745 110585553

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FX12 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Other monoclonal antibodies and antibody drug conjugates
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 vedotinepcoritamabgemtuzumab ozogamicinglofitamab show all 29 →

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

DiseaseRelationSNOMED_IDDOID
Malignant lymphoma, large B-cell, diffuse indication 46732000
Diffuse large B-cell lymphoma refractory indication




🐶 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
B-lymphocyte antigen CD19 Surface antigen ANTIBODY BINDING Kd 9.39 DRUG LABEL DRUG LABEL

External reference:

IDSource
D11601 KEGG_DRUG
QQA9MLH692 UNII
4039607 VANDF
4039608 VANDF
C5139916 UMLSCUI
CHEBI:757470 CHEBI
CHEMBL4298047 ChEMBL_ID
DB15044 DRUGBANK_ID
10835 INN_ID
C000613469 MESH_SUPPLEMENTAL_RECORD_UI
11131 IUPHAR_LIGAND_ID
896700009 SNOMEDCT_US
896714009 SNOMEDCT_US
337004 MMSL
38711 MMSL
d09611 MMSL
018464 NDDF
2387211 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
MONJUVI HUMAN PRESCRIPTION DRUG LABEL 1 50881-013 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS BLA 28 sections
MONJUVI HUMAN PRESCRIPTION DRUG LABEL 1 50881-013 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS BLA 28 sections
MONJUVI HUMAN PRESCRIPTION DRUG LABEL 1 73535-208 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS BLA 28 sections