Zynlonta, Zynlonta (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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
| immune system diseases | D007154 |
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 |
|---|---|---|---|---|---|
| Zynlonta | loncastuximab tesirine-lpyl | ADC Therapeutics | N-761196 RX | 2021-04-23 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zynlonta | Biologic Licensing Application | 2024-07-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| large b-cell lymphoma diffuse | — | D016403 | C83.3 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
loncastuximab tesirine, Zynlonta, ADC Therapeutics SA | |||
| 2028-04-23 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9359 | Injection, loncastuximab tesirine-lpyl, 0.075 mg |
Clinical
Clinical Trials
31 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 |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 11 | 14 | 2 | — | 2 | 26 |
| B-cell lymphoma | D016393 | — | — | 8 | 9 | 2 | — | 2 | 19 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 7 | 8 | 1 | — | 1 | 15 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 4 | 4 | 1 | — | — | 7 |
| Hodgkin disease | D006689 | — | C81 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Follicular lymphoma | D008224 | — | C82 | 4 | 5 | — | — | — | 8 |
| Mantle-cell lymphoma | D020522 | — | — | 4 | 4 | — | — | — | 6 |
| Leukemia | D007938 | — | C95 | 2 | 1 | — | — | — | 3 |
| Lymphoid leukemia | D007945 | — | C91 | 2 | 1 | — | — | — | 3 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 2 | 1 | — | — | — | 3 |
| Recurrence | D012008 | — | — | 1 | 2 | — | — | — | 3 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 1 | 2 | — | — | — | 2 |
| Waldenstrom macroglobulinemia | D008258 | HP_0005508 | C88.0 | 1 | 1 | — | — | — | 2 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Burkitt lymphoma | D002051 | — | C83.7 | 2 | — | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 1 | — | — | — | — | 1 |
| Central nervous system neoplasms | D016543 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 1 | 1 |
| Agranulocytosis | D000380 | HP_0012234 | D70 | — | — | — | — | 1 | 1 |
| Toxemia | D014115 | — | — | — | — | — | — | 1 | 1 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Loncastuximab tesirine |
| INN | loncastuximab 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 class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1879918-31-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297778 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16222 |
| UNII ID | 7K5O7P6QIU (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
Variants
No data
Financial
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Trends
PubMed Central
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Additional graphs summarizing 420 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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188 adverse events reported
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