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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
Therapeutic Area
MeSH
neoplasmsD009369
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
immune system diseasesD007154
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
Tecvayliteclistamab-cqyvJohnson & JohnsonN-761291 RX2022-10-25
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
tecvayliBiologic Licensing Application2022-10-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
multiple myelomaD009101C90.0
Agency Specific
FDA
EMA
Expiration
Code
teclistamab, Tecvayli, Janssen Biotech, Inc.
2029-10-25Orphan 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
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101C90.0434213
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD019337223
Smoldering multiple myelomaD00007512211
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTECLISTAMAB
INNteclistamab
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 classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID2119595-80-9
RxCUI
ChEMBL IDCHEMBL4594505
ChEBI ID
PubChem CID
DrugBankDB16655
UNII ID54534MX6Z9 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
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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