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Drug ReportsTAFASITAMAB-CXIX
TAFASITAMAB
Minjuvi, Monjuvi (tafasitamab) is an antibody pharmaceutical. Tafasitamab was first approved as Monjuvi on 2020-07-31. 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. The pharmaceutical is active against B-lymphocyte antigen CD19.
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YTD
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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
Monjuvi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
large b-cell lymphoma diffuse—D016403C83.3
Agency Specific
FDA
EMA
Expiration
Code
tafasitamab, Monjuvi, MorphoSys US Inc.
2027-07-31Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FX: Other monoclonal antibodies and antibody drug conjugates in atc
— L01FX12: Tafasitamab
HCPCS
Code
Description
J9349
Injection, tafasitamab-cxix, 2 mg
Clinical
Clinical Trials
46 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Large b-cell lymphoma diffuseD016403—C83.3583—214
B-cell lymphomaD016393——221——4
Follicular lymphomaD008224—C82111——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell chronic lymphocytic leukemiaD015451—C91.124———5
Non-hodgkin lymphomaD008228—C85.934———5
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.012———2
Prolymphocytic leukemiaD015463———1———1
Hodgkin diseaseD006689—C81—1———1
Philadelphia chromosomeD010677———1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTAFASITAMAB
INNtafasitamab
Description
Tafasitamab, sold under the brand name Monjuvi, is a medication used in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Classification
Antibody
Drug classmonoclonal antibodies
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1422527-84-1
RxCUI—
ChEMBL IDCHEMBL4298047
ChEBI ID—
PubChem CID—
DrugBankDB15044
UNII IDQQA9MLH692 (ChemIDplus, GSRS)
Target
Agency Approved
CD19
CD19
Organism
Homo sapiens
Gene name
CD19
Gene synonyms
NCBI Gene ID
Protein name
B-lymphocyte antigen CD19
Protein synonyms
B-lymphocyte surface antigen B4, CD19, Differentiation antigen CD19, T-cell surface antigen Leu-12
Uniprot ID
Mouse ortholog
Cd19 (12478)
B-lymphocyte antigen CD19 (Q542B2)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Minjuvi – Incyte
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 505 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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118 adverse events reported
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