Kymriah
E584153
Kymriah is a pioneering CAR-T cell therapy used to treat certain types of blood cancers by genetically modifying a patient’s own immune cells to target and destroy malignant cells.
Observed surface forms (1)
| Surface form | Occurrences |
|---|---|
| tisagenlecleucel | 0 |
Statements (50)
| Predicate | Object |
|---|---|
| instanceOf |
CAR-T cell therapy
ⓘ
gene therapy medicinal product ⓘ oncology drug ⓘ prescription medicine ⓘ |
| administrationRoute | intravenous infusion ⓘ |
| adverseEffect |
cytokine release syndrome
ⓘ
hypogammaglobulinemia ⓘ infections ⓘ neurotoxicity ⓘ prolonged cytopenias ⓘ |
| ATCCode | L01XL01 ⓘ |
| belongsToCategory | advanced therapy medicinal product ⓘ |
| boxedWarning |
cytokine release syndrome
ⓘ
neurological toxicities ⓘ |
| developer | Novartis NERFINISHED ⓘ |
| firstEMAApprovalDate | 2018-08-27 ⓘ |
| firstFDAApprovalDate | 2017-08-30 ⓘ |
| firstIndication | pediatric and young adult relapsed or refractory B-cell precursor acute lymphoblastic leukemia ⓘ |
| firstIndicationRegion | United States NERFINISHED ⓘ |
| hasTradeName | Kymriah NERFINISHED ⓘ |
| indication |
adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy
ⓘ
adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy ⓘ pediatric and young adult patients with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse ⓘ |
| legalStatusEU | prescription-only ⓘ |
| legalStatusUS | prescription-only ⓘ |
| manufacturingProcess | ex vivo genetic modification of T cells with a lentiviral vector encoding a chimeric antigen receptor ⓘ |
| marketingAuthorizationHolder | Novartis Pharma AG NERFINISHED ⓘ |
| mechanismOfAction | CD19-directed genetically modified autologous T cell immunotherapy ⓘ |
| molecularTarget | CD19 NERFINISHED ⓘ |
| notableFeature | first CAR-T cell therapy approved by the US FDA ⓘ |
| patientPopulation |
adult patients
ⓘ
pediatric patients ⓘ young adult patients ⓘ |
| pharmacologicalClass | antineoplastic agent ⓘ |
| regulatoryStatus |
EMA-approved
ⓘ
FDA-approved ⓘ |
| requires | leukapheresis of patient T cells ⓘ |
| requiresMonitoring | hospitalization and monitoring for cytokine release syndrome ⓘ |
| requiresPreconditioning | lymphodepleting chemotherapy ⓘ |
| routeOfManufacture | centralized manufacturing at specialized facilities ⓘ |
| storage | cryopreserved suspension for intravenous infusion ⓘ |
| targetsDisease |
B-cell acute lymphoblastic leukemia
ⓘ
DLBCL arising from follicular lymphoma ⓘ diffuse large B-cell lymphoma NERFINISHED ⓘ follicular lymphoma ⓘ high-grade B-cell lymphoma ⓘ |
| therapyType |
immunotherapy
ⓘ
personalized medicine ⓘ |
| tradeNameOf | tisagenlecleucel NERFINISHED ⓘ |
| usesCellType | autologous T lymphocytes ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.