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Carvykti(ciltacabtagene autoleucel)
Carvykti (ciltacabtagene autoleucel) is a gene pharmaceutical. Ciltacabtagene autoleucel was first approved as Carvykti on 2022-02-28. 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
Carvykti
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)
Ciltacabtagene autoleucel
Tradename
Proper name
Company
Number
Date
Products
Carvykticiltacabtagene autoleucelJohnson & JohnsonN-125746 RX2022-02-28
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
carvyktiBiologic Licensing Application2022-03-09
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
multiple myeloma—D009101C90.0
Agency Specific
FDA
EMA
Expiration
Code
ciltacabtagene autoleucel, Carvykti, Janssen Biotech, Inc.
2029-02-28Orphan excl.
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
13 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 myelomaD009101C90.02531211
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 nameCILTACABTAGENE AUTOLEUCEL
INNciltacabtagene autoleucel
Description
Ciltacabtagene autoleucel, sold under the brand name Carvykti, is an anti-cancer medication used to treat multiple myeloma. Ciltacabtagene autoleucel is a BCMA (B-cell maturation antigen)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. Each dose is customized using the recipient's own T-cells, which are collected and genetically modified, and infused back into the recipient.
Classification
Gene
Drug classAntineoplastic
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4802263
ChEBI ID—
PubChem CID—
DrugBankDB16738
UNII ID0L1F17908Q (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Carvykti - Johnson & Johnson
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 385 documents
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Safety
Black-box Warning
Black-box warning for: Carvykti
Adverse Events
Top Adverse Reactions
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6 adverse events reported
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