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Monjuvi, Minjuvi(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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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Monjuvi
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)
Tafasitamab
Tradename
Proper name
Company
Number
Date
Products
Monjuvitafasitamab-cxixMorphoSys US Inc.N-761163 RX2020-07-31
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
monjuviBiologic Licensing Application2020-09-09
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
38 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
Large b-cell lymphoma diffuseD016403C83.3683——12
B-cell lymphomaD016393121——3
Follicular lymphomaD008224C82111——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell chronic lymphocytic leukemiaD015451C91.124———5
Non-hodgkin lymphomaD008228C85.934———5
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.012———2
Prolymphocytic leukemiaD015463—1———1
Hodgkin diseaseD006689C81—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
Image (chem structure or protein)
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
930
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
P15391
Mouse ortholog
Cd19 (12478)
B-lymphocyte antigen CD19 (Q542B2)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Minjuvi - Incyte
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 301 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,244 adverse events reported
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