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.

All labels observed (4)

Label Occurrences
Kymriah canonical 3
Abecma 1
CAR T-cell therapies 1

How this entity was disambiguated

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
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
hasTradeName Kymriah
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
linked to: Novartis
mechanismOfAction CD19-directed genetically modified autologous T cell immunotherapy
molecularTarget CD19
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
follicular lymphoma
high-grade B-cell lymphoma
therapyType immunotherapy
personalized medicine
tradeNameOf tisagenlecleucel
linked to: Kymriah
usesCellType autologous T lymphocytes

How these facts were elicited

Referenced by (6)

Full triples — surface form annotated when it differs from this entity's canonical label.

Novartis notableDrug Kymriah
Bristol Myers Squibb product Abecma
linked to: Kymriah
Novartis notableProduct Kymriah
subject linked to: NOVN
Kymriah tradeNameOf tisagenlecleucel
linked to: Kymriah
tisagenlecleucel hasTradeName Kymriah
subject linked to: Kymriah
CD22 targetOf CAR T-cell therapies
linked to: Kymriah