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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Kymriah
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
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Indications
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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
84 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 9 | 6 | 3 | — | 5 | 20 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 7 | 4 | 2 | — | 6 | 18 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 2 | 6 | 1 | — | — | 9 |
| Follicular lymphoma | D008224 | — | C82 | 2 | 3 | 1 | — | 3 | 8 |
| B-cell lymphoma | D016393 | — | — | 4 | 3 | 1 | — | 2 | 8 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 3 | 4 | 1 | — | — | 7 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 5 | — | 1 | — | 1 | 7 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 2 | 2 | 1 | — | 1 | 5 |
| Burkitt lymphoma | D002051 | — | C83.7 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 2 | 1 | — | — | 1 | 4 |
| Lymphoma | D008223 | — | C85.9 | 2 | 1 | — | — | 2 | 4 |
| B-cell leukemia | D015448 | — | — | 2 | 2 | — | — | 1 | 3 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | 1 | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biphenotypic leukemia acute | D015456 | — | C95.0 | 2 | — | — | — | 1 | 3 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | — | — | — | — | 2 |
| Leukemia | D007938 | — | C95 | 2 | — | — | — | — | 2 |
| Hodgkin disease | D006689 | — | C81 | 2 | — | — | — | — | 2 |
| Prolymphocytic leukemia | D015463 | — | — | 1 | — | — | — | 1 | 2 |
| Residual neoplasm | D018365 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cytokine release syndrome | D000080424 | — | D89.83 | — | — | — | — | 1 | 1 |
| Myocarditis | D009205 | — | I51.4 | — | — | — | — | 1 | 1 |
| Lymphoid leukemia | D007945 | — | C91 | — | — | — | — | 1 | 1 |
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
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Kymriah – Novartis
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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2,325 adverse events reported
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