Kymriah(tisagenlecleucel)
Kymriah (tisagenlecleucel) is a cell pharmaceutical. Tisagenlecleucel was first approved as Kymriah on 2017-08-30. It has been approved in Europe to treat large b-cell lymphoma diffuse and precursor b-cell lymphoblastic leukemia-lymphoma.
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Novartis Pharmaceuticals
Drugs Approved for Childhood Cancers
Commercial
Trade Name
FDA
EMA
Kymriah
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)
Tisagenlecleucel
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Kymriah | Tisagenlecleucel | Novartis Pharmaceuticals Corporation | A-125646 RX | 2017-08-30 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| kymriah | Biologic Licensing Application | 2021-08-13 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
tisagenlecleucel, Kymriah, Novartis Pharmaceuticals Corporation | |||
| 2029-05-27 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| Q2042 | Tisagenlecleucel, up to 600 million car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
Clinical
Clinical Trials
57 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 5 | — | — | — | — | 5 | |
| Biphenotypic leukemia acute | D015456 | C95.0 | 2 | — | — | — | — | 2 | |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Leukemia | D007938 | C95 | 1 | — | — | — | — | 1 | |
| Hodgkin disease | D006689 | C81 | 1 | — | — | — | — | 1 | |
| Residual neoplasm | D018365 | 1 | — | — | — | — | 1 | ||
| Prolymphocytic leukemia | D015463 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | TISAGENLECLEUCEL |
| INN | tisagenlecleucel |
| Description | Tisagenlecleucel, sold under the brand name Kymriah, is a CAR T cells medication for the treatment of B-cell acute lymphoblastic leukemia (ALL) which uses the body's own T cells to fight cancer (adoptive cell transfer).
|
| Classification | Cell |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | 1986438 |
| ChEMBL ID | CHEMBL3301574 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB13881 |
| UNII ID | Q6C9WHR03O (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Kymriah - Novartis
$
€
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,038 documents
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Safety
Black-box Warning
Black-box warning for: Kymriah
Adverse Events
Top Adverse Reactions
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6 adverse events reported
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