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Zynlonta, Zynlonta (loncastuximab tesirine)
Zynlonta (loncastuximab tesirine) is an antibody pharmaceutical. Loncastuximab tesirine was first approved as Zynlonta on 2021-04-23. It is used to treat large b-cell lymphoma diffuse in the USA. It has been approved in Europe to treat b-cell lymphoma and large b-cell lymphoma diffuse. It is known to target B-lymphocyte antigen CD19.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Zynlonta
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)
Loncastuximab tesirine
Tradename
Proper name
Company
Number
Date
Products
Zynlontaloncastuximab tesirine-lpylADC TherapeuticsN-761196 RX2021-04-23
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
zynlontaBiologic Licensing Application2021-05-17
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
large b-cell lymphoma diffuse—D016403C83.3
Agency Specific
FDA
EMA
Expiration
Code
loncastuximab tesirine, Zynlonta, ADC Therapeutics SA
2028-04-23Orphan excl.
Patent Expiration
No data
ATC Codes
No data
HCPCS
Code
Description
C9084
Injection, loncastuximab tesirine-lpyl, 0.1 mg
Clinical
Clinical Trials
10 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AlcoholismD000437EFO_0003829F10.112———3
SchizophreniaD012559EFO_0000692F20—2———2
Binge-eating disorderD056912F50.2—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
Cocaine-related disordersD019970F141————1
Substance-related disordersD019966EFO_0003890F131————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLONCASTUXIMAB TESIRINE
INNloncastuximab tesirine
Description
Loncastuximab tesirine, sold under the brand name Zynlonta, is a monoclonal antibody conjugate medication used to treat large B-cell lymphoma and high-grade B-cell lymphoma. It is an antibody-drug conjugate (ADC) composed of a humanized antibody targeting the protein CD19.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1879918-31-6
RxCUI—
ChEMBL IDCHEMBL4297778
ChEBI ID—
PubChem CID—
DrugBankDB16222
UNII ID7K5O7P6QIU (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
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)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 240 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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2 adverse events reported
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