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Drug ReportsLoncastuximab tesirine
Loncastuximab tesirine
Zynlonta (loncastuximab tesirine) is an antibody drug conjugate 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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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Events
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
Zynlonta
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
loncastuximab tesirine, Zynlonta, ADC Therapeutics SA
2028-04-23Orphan 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
— L01FX22: Loncastuximab tesirine
HCPCS
Code
Description
J9359
Injection, loncastuximab tesirine-lpyl, 0.075 mg
Clinical
Clinical Trials
30 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 diffuseD016403—C83.3661—113
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Follicular lymphomaD008224—C8235———7
Mantle-cell lymphomaD020522—C83.144———6
Non-hodgkin lymphomaD008228—C85.942———5
B-cell lymphomaD016393——22———4
LymphomaD008223—C85.911———2
B-cell chronic lymphocytic leukemiaD015451—C91.111———2
Waldenstrom macroglobulinemiaD008258HP_0005508C88.011———2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Burkitt lymphomaD002051—C83.72————2
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.01————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SepsisD018805HP_0100806A41.9————11
AgranulocytosisD000380HP_0012234D70————11
Opportunistic infectionsD009894——————11
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)Loading
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
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)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 348 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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15 adverse events reported
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