tafasitamab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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

Approvals:

DateAgencyCompanyOrphan
Aug. 26, 2021 EMA INCYTE BIOSCIENCES DISTRIBUTION B.V.
July 31, 2020 FDA MORPHOSYS US INC

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
Lymphoma 271.98 73.52 54 647 12133 63476188
Disease progression 144.62 73.52 53 648 122705 63365616
Gastric cancer 75.86 73.52 16 685 4707 63483614

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
Lymphoma 314.62 64.48 67 598 12440 34943826
Disease progression 193.58 64.48 73 592 108004 34848262
Off label use 86.27 64.48 67 598 419457 34536809

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 243.16 55.59 92 1023 184270 79559003
Lymphoma 144.59 55.59 36 1079 17424 79725849
Off label use 127.03 55.59 102 1013 907113 78836160
Testicular disorder 61.23 55.59 9 1106 255 79743018
Necrotic lymphadenopathy 61.17 55.59 8 1107 93 79743180

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

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
C5139916 UMLSCUI
CHEMBL4298047 ChEMBL_ID
DB15044 DRUGBANK_ID
11131 IUPHAR_LIGAND_ID
018464 NDDF
896700009 SNOMEDCT_US
896714009 SNOMEDCT_US
4039607 VANDF
4039608 VANDF
2387211 RXNORM
337004 MMSL
38711 MMSL
d09611 MMSL
C000613469 MESH_SUPPLEMENTAL_RECORD_UI
10835 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
MONJUVI HUMAN PRESCRIPTION DRUG LABEL 1 73535-208 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