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Tecartus(brexucabtagene autoleucel)
Tecartus (brexucabtagene autoleucel) is a gene pharmaceutical. Brexucabtagene autoleucel was first approved as Tecartus on 2020-07-24. It is used to treat mantle-cell lymphoma in the USA. It has been approved in Europe to treat mantle-cell lymphoma.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Tecartus
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)
Brexucabtagene autoleucel
Tradename
Proper name
Company
Number
Date
Products
TecartusBrexucabtagene AutoleucelGilead SciencesA-125703 RX2020-07-24
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
tecartusBiologic Licensing Application2022-02-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mantle-cell lymphoma—D020522C83.1
Agency Specific
FDA
EMA
Expiration
Code
brexucabtagene autoleucel, Tecartus, Kite Pharma Inc.
2028-10-01Orphan excl.
Patent Expiration
No data
ATC Codes
No data
HCPCS
Code
Description
Q2053
Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose
Clinical
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
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 nameBREXUCABTAGENE AUTOLEUCEL
INNbrexucabtagene autoleucel
Description
Brexucabtagene autoleucel, sold under the brand name Tecartus, is a cell-based gene therapy medication for the treatment of mantle cell lymphoma (MCL) and acute lymphoblastic leukemia (ALL).
Classification
Gene
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4594618
ChEBI ID—
PubChem CID—
DrugBankDB15699
UNII ID4MD2J2T8SJ (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Tecartus - Gilead Sciences
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 600 documents
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Safety
Black-box Warning
Black-box warning for: Tecartus
Adverse Events
Top Adverse Reactions
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2 adverse events reported
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