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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
| immune system diseases | D007154 |
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 | 2024-06-19 |
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
44 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 10 | 18 | 3 | 1 | 6 | 35 |
| B-cell lymphoma | D016393 | — | — | 8 | 13 | 2 | 1 | 6 | 27 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 6 | 8 | 1 | — | 6 | 18 |
| Follicular lymphoma | D008224 | — | C82 | 2 | 7 | 1 | — | 1 | 10 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 4 | 5 | — | — | — | 7 |
| Neurotoxicity syndromes | D020258 | — | G92 | 1 | 2 | — | — | — | 3 |
| Recurrence | D012008 | — | — | 1 | 2 | — | — | — | 3 |
| Hematologic neoplasms | D019337 | — | — | — | 2 | — | — | — | 2 |
| Cytokine release syndrome | D000080424 | — | D89.83 | — | 2 | — | — | — | 2 |
| Syndrome | D013577 | — | — | — | 2 | — | — | — | 2 |
| Disease progression | D018450 | — | — | — | 1 | — | — | — | 1 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | 1 | — | — | — | 1 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | — | 1 | — | — | — | 1 |
| Mantle-cell lymphoma | D020522 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | — | 1 |
| Aids-related lymphoma | D016483 | EFO_1001365 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | — | — | — | — | 3 | 3 |
| Cell- and tissue-based therapy | D064987 | — | — | — | — | — | — | 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.
|
| 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
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Variants
No data
Financial
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Yescarta – Gilead Sciences
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 4,813 documents
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Safety
Black-box Warning
Black-box warning for: Yescarta
Adverse Events
Top Adverse Reactions
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6,316 adverse events reported
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