Tecvayli(teclistamab)
Tecvayli (teclistamab) is an antibody pharmaceutical. Teclistamab was first approved as Tecvayli on 2022-08-23. It is used to treat multiple myeloma in the USA. It has been approved in Europe to treat multiple myeloma.
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Commercial
Therapeutic Areas
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Tecvayli
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)
Teclistamab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Tecvayli | teclistamab-cqyv | Johnson & Johnson | N-761291 RX | 2022-10-25 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tecvayli | Biologic Licensing Application | 2026-03-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple myeloma | — | D009101 | C90.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
teclistamab, Tecvayli, Janssen Biotech, Inc. | |||
| 2029-10-25 | Orphan excl. | ||
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Clinical
Clinical Trials
57 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 11 | 23 | 7 | 3 | 8 | 48 |
| Recurrence | D012008 | — | — | 2 | 1 | 2 | 1 | — | 6 |
| Neoplasms | D009369 | — | C80 | — | — | — | 1 | — | 1 |
| Waldenstrom macroglobulinemia | D008258 | — | C88.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasma cell neoplasms | D054219 | — | — | 1 | 9 | — | — | 5 | 15 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | 4 | — | — | 2 | 6 |
| Hematologic neoplasms | D019337 | — | — | 3 | 4 | — | — | — | 4 |
| Smoldering multiple myeloma | D000075122 | — | — | — | 2 | — | — | — | 2 |
| Cytokine release syndrome | D000080424 | — | D89.83 | — | 2 | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 1 | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | 1 | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 1 | — | — | — | 1 |
| T-cell lymphoma peripheral | D016411 | — | — | 1 | 1 | — | — | — | 1 |
| Neurotoxicity syndromes | D020258 | — | G92 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasmablastic lymphoma | D000069293 | — | C83.3 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | — | — | 1 | 1 |
| Plasma cell leukemia | D007952 | — | C90.1 | — | — | — | — | 1 | 1 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Teclistamab |
| INN | teclistamab |
| Description | Teclistamab, sold under the brand name Tecvayli, is a human bispecific monoclonal antibody used for the treatment of relapsed and refractory multiple myeloma. It is a bispecific antibody that targets the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 2119595-80-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4594505 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16655 |
| UNII ID | 54534MX6Z9 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Tecvayli – Johnson & Johnson
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Trends
PubMed Central
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Additional graphs summarizing 1,333 documents
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Safety
Black-box Warning
Black-box warning for: Tecvayli
Adverse Events
Top Adverse Reactions
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3,068 adverse events reported
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