Yescarta(axicabtagene ciloleucel)
Yescarta (axicabtagene ciloleucel) is a gene pharmaceutical. Axicabtagene ciloleucel was first approved as Yescarta on 2017-10-18. It has been approved in Europe to treat follicular lymphoma and large b-cell lymphoma diffuse.
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Trade Name
FDA
EMA
Yescarta
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)
Axicabtagene ciloleucel
Tradename | Proper name | Company | Number | Date | Products |
---|---|---|---|---|---|
Yescarta | axicabtagene ciloleucel | Gilead Sciences | A-125643 RX | 2017-10-18 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
yescarta | Biologic Licensing Application | 2021-04-28 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
axicabtagene ciloleucel, Yescarta, Kite Pharma Inc. | |||
2029-04-01 | Orphan excl. |
Patent Expiration
No data
HCPCS
Code | Description |
---|---|
Q2041 | Axicabtagene ciloleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
Clinical
Clinical Trials
28 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
B-cell lymphoma | D016393 | 2 | 8 | — | — | 1 | 10 | ||
Large b-cell lymphoma diffuse | D016403 | C83.3 | 4 | 5 | — | — | 1 | 8 | |
Follicular lymphoma | D008224 | C82 | 2 | 3 | — | — | — | 4 | |
Non-hodgkin lymphoma | D008228 | C85.9 | 2 | 2 | — | — | — | 3 | |
Cytokine release syndrome | D000080424 | D89.83 | — | 2 | — | — | — | 2 | |
Neurotoxicity syndromes | D020258 | G92 | — | 1 | — | — | — | 1 | |
Hematologic neoplasms | D019337 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Lymphoma | D008223 | C85.9 | 1 | — | — | — | — | 1 | |
Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | AXICABTAGENE CILOLEUCEL |
INN | axicabtagene ciloleucel |
Description | Axicabtagene ciloleucel, sold under the brand name Yescarta, is a medication used for the treatment for large B-cell lymphoma that has failed conventional treatment. T cells are removed from a person with lymphoma and genetically engineered to produce a specific T-cell receptor. The resulting chimeric antigen receptor T cells (CAR-Ts) that react to the cancer are then given back to the person to populate the bone marrow. Axicabtagene treatment carries a risk for cytokine release syndrome (CRS) and neurological toxicities.
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Classification | Gene |
Drug class | — |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
PDB | — |
CAS-ID | — |
RxCUI | 1987398 |
ChEMBL ID | CHEMBL3989989 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB13915 |
UNII ID | U2I8T43Y7R (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Yescarta - Gilead Sciences
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,376 documents
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Safety
Black-box Warning
Black-box warning for: Yescarta
Adverse Events
Top Adverse Reactions
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1,851 adverse events reported
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