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
Trade Name
FDA
EMA
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 |
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Tecvayli | teclistamab-cqyv | Johnson & Johnson | N-761291 RX | 2022-10-25 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
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tecvayli | Biologic Licensing Application | 2022-10-31 |
Agency Specific
FDA
EMA
Expiration | Code | ||
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teclistamab, Tecvayli, Janssen Biotech, Inc. | |||
2029-10-25 | Orphan excl. |
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
17 clinical trials
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Indications Phases 4
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
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Hematologic neoplasms | D019337 | 2 | 2 | — | — | — | 3 | ||
Smoldering multiple myeloma | D000075122 | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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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.
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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
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 213 documents
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Safety
Black-box Warning
Black-box warning for: Tecvayli
Adverse Events
Top Adverse Reactions
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5 adverse events reported
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