Statements (53)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:drug
gene therapy |
| gptkbp:administeredBy |
intravenous infusion
lymphodepleting chemotherapy |
| gptkbp:approvedBy |
gptkb:European_Union
gptkb:United_States gptkb:FDA gptkb:EMA 2021-02-05 |
| gptkbp:ATCCode |
L01XL10
|
| gptkbp:blackBoxWarning |
cytokine release syndrome
neurological toxicities |
| gptkbp:brand |
gptkb:Breyanzi
|
| gptkbp:clinicalTrialPhase |
gptkb:TRANSCEND_NHL_001
|
| gptkbp:cost |
high
|
| gptkbp:developer |
gptkb:Juno_Therapeutics
gptkb:Bristol_Myers_Squibb |
| gptkbp:drugClass |
antineoplastic agent
|
| gptkbp:form |
cell suspension
|
| gptkbp:geneticModification |
chimeric antigen receptor (CAR) targeting CD19
|
| https://www.w3.org/2000/01/rdf-schema#label |
lisocabtagene maraleucel
|
| gptkbp:indication |
patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
|
| gptkbp:legalStatus |
prescription only
|
| gptkbp:manufacturingTime |
2-4 weeks
|
| gptkbp:mechanismOfAction |
CD19-directed genetically modified autologous T cells
|
| gptkbp:MedlinePlusID |
a621027
|
| gptkbp:monitors |
hospitalization for monitoring after infusion
|
| gptkbp:orphanDrugStatus |
yes
|
| gptkbp:pregnancyCategory |
not recommended
|
| gptkbp:prescriptionRequired |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125726s000lbl.pdf
|
| gptkbp:routeOfAdministration |
intravenous
|
| gptkbp:RxNorm |
2468232
|
| gptkbp:sideEffect |
gptkb:anemia
infections thrombocytopenia cytokine release syndrome febrile neutropenia neurological toxicities |
| gptkbp:source |
autologous T cells
|
| gptkbp:storage |
cryopreserved
-150°C or below |
| gptkbp:target |
gptkb:CD19
|
| gptkbp:type |
autologous cell therapy
|
| gptkbp:UNII |
Q2V4Z1FQ6F
|
| gptkbp:usedFor |
gptkb:large_B-cell_lymphoma
gptkb:primary_mediastinal_large_B-cell_lymphoma relapsed or refractory diffuse large B-cell lymphoma high grade B-cell lymphoma follicular lymphoma grade 3B |
| gptkbp:bfsParent |
gptkb:JCAR017
gptkb:CD19 gptkb:Breyanzi |
| gptkbp:bfsLayer |
6
|