Preferred Label : Lisocabtagene Maraleucel;
NCIt synonyms : Anti-CD19-CAR Genetically Engineered Autologous T-lymphocytes JCAR017; Autologous Anti-CD19-EGFRt-4-1BB-zeta-modified CAR CD8 and CD4 T-lymphocytes JCAR017; Anti-CD19-CAR Genetically Engineered Autologous T Lymphocytes JCAR017; Liso-cel;
NCIt definition : A preparation of a defined ratio of CD4 and CD8 autologous T-lymphocytes transduced
with a lentiviral vector expressing a chimeric antigen receptor (CAR) containing an
anti-CD19 single chain variable fragment (scFv) fused to the signaling domain of 4-1BB
(CD137), the zeta chain of the TCR/CD3 complex (CD3-zeta), and a truncated form of
the human epidermal growth factor receptor (EGFRt), with potential immunostimulating
and antineoplastic activities. Upon intravenous administration, lisocabtagene maraleucel
is directed to and induces selective toxicity in CD19-expressing tumor cells. CD19
antigen is a B-cell specific cell surface antigen expressed in all B-cell lineage
malignancies. Devoid of both ligand binding domains and tyrosine kinase activity,
the expressed EGFRt both facilitates in vivo detection of the administered, transduced
T-cells and can promote elimination of those cells through a cetuximab-induced antibody
dependent cellular cytotoxicity (ADCC) response. The 4-1BB costimulatory signaling
domain enhances both proliferation of T-cells and antitumor activity.;
UNII : 7K2YOJ14X0;
Drug name : Breyanzi;
Molecule name : JCAR-017; JCAR 017;
NCI Metathesaurus CUI : CL504006;
Codes from synonyms : 21215;
Origin ID : C125192;
UMLS CUI : C4086001;
Currated CISMeF NLP mapping
Semantic type(s)
- Cell [UMLS semantic type]
UMLS correspondences (same concept)
chemical_or_drug_affects_cell_type_or_tissue
chemical_or_drug_has_mechanism_of_action
chemical_or_drug_has_physiologic_effect
concept_is_in_subset
has_target
is_component_of_chemotherapy_regimen
https://ansm.sante.fr/tableau-marr/lisocabtagene-maraleucel
2025
false
false
false
France
French
guidelines for drug use
risk management
Lisocabtagene Maraleucel
Lisocabtagene Maraleucel
Product containing only lisocabtagene maraleucel in parenteral dose form (medicinal
product form)
Cytokine Release Syndrome
continuity of patient care
gene therapy
immunotherapy, adoptive
signs and symptoms
nervous system diseases
patients guideline
lisocabtagene maraleucel
---
https://ansm.sante.fr/tableau-acces-derogatoire/breyanzi
2024
false
false
false
France
French
Lisocabtagene Maraleucel
Product containing only lisocabtagene maraleucel in parenteral dose form (medicinal
product form)
summary of product characteristics
package leaflet
guidelines for drug use
lymphoma, large B-Cell, diffuse
adult
Recurrent High Grade B-Cell Lymphoma
Refractory High Grade B-Cell Lymphoma
Recurrent Primary Mediastinal Large B-Cell Lymphoma
Refractory Primary Mediastinal Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
infusions, intravenous
continuity of patient care
immunotherapy, adoptive
antigens, CD19
lisocabtagene maraleucel
---
https://ansm.sante.fr/actualites/decision-du-18-10-2023-fixant-le-seuil-du-stock-de-securite-destine-au-marche-national-prevue-a-larticle-r-5124-49-4-iii-du-csp-pour-le-mitm-breyanzi-1-1-70-x-106-cellules-ml-1-1-70-x-106-cellules-ml-dispersion-pour-perfusion
2023
false
false
false
France
French
drug information
Lisocabtagene Maraleucel
---
https://www.has-sante.fr/jcms/p_3463592/fr/breyanzi-lisocabtagene-maraleucel-lymphome-folliculaire-de-grade-3b-lf3b
2023
false
false
false
France
treatment outcome
insurance, health, reimbursement
lymphoma, large B-Cell, diffuse
High Grade B-Cell Lymphoma
adult
Primary Mediastinal Large B-Cell Lymphoma
immunotherapy, adoptive
gene therapy
infusions, intravenous
evaluation of the transparency committee
Grade 3b Follicular Lymphoma
Lisocabtagene Maraleucel
lymphoma, follicular
---
https://www.has-sante.fr/jcms/p_3465836/fr/breyanzi-lisocabtagene-maraleucel-lymphome-diffus-a-grandes-cellules-b-ldgcb-lymphome-de-haut-grade-a-cellules-b-lhgcb-lymphome-mediastinal-primitif-a-grandes-cellules-b-lmpgcb-et-lymphome-folliculaire-de-grade-3b-lf3b
2023
false
false
false
France
French
evaluation of the transparency committee
insurance, health, reimbursement
treatment outcome
lymphoma, large B-Cell, diffuse
lymphoma, follicular
mediastinal neoplasms
Grade 3b Follicular Lymphoma
Primary Mediastinal Large B-Cell Lymphoma
High Grade B-Cell Lymphoma
Antineoplastic Agents, Immunological
Lisocabtagene Maraleucel
gene therapy
adult
infusions, intravenous
lisocabtagene maraleucel
---
https://www.ema.europa.eu/en/medicines/human/EPAR/breyanzi
2022
false
false
false
Netherlands
French
English
treatment outcome
syndication feed
summary of product characteristics
package leaflet
drug evaluation
Lisocabtagene Maraleucel
Lisocabtagene Maraleucel
gene therapy
drug approval
europe
adult
lymphoma, large B-Cell, diffuse
Primary Mediastinal Large B-Cell Lymphoma
Grade 3b Follicular Lymphoma
lymphoma, follicular
infusions, intravenous
Cytokine Release Syndrome
pregnancy
breast feeding
drug interactions
Receptors, Chimeric Antigen
product surveillance, postmarketing
Anti-CD19 CAR T Cells Preparation
aged
continuity of patient care
immunotherapy, adoptive
drug evaluation, preclinical
mediastinal neoplasms
lisocabtagene maraleucel
---
https://www.has-sante.fr/jcms/p_3368313/fr/breyanzi-lisocabtagene-maraleucel-liso-cel-ldgcb
2022
false
false
false
France
treatment outcome
insurance, health, reimbursement
Lisocabtagene Maraleucel
lymphoma, large B-Cell, diffuse
adult
High Grade B-Cell Lymphoma
Recurrent Primary Mediastinal Large B-Cell Lymphoma
Refractory Primary Mediastinal Large B-Cell Lymphoma
guidelines for drug use
Product containing only lisocabtagene maraleucel in parenteral dose form (medicinal
product form)
continuity of patient care
immunotherapy, adoptive
infusions, intravenous
lisocabtagene maraleucel
evaluation of the transparency committee
---
2021
false
false
false
Canada
French
Lisocabtagene Maraleucel
drug information
canada
immunotherapy, adoptive
gene therapy
lymphoma, large B-Cell, diffuse
genetic therapy
---
https://www.cadth.ca/fr/lisocabtagene-maraleucel
2021
false
false
false
Canada
French
Lisocabtagene Maraleucel
drug information
lymphoma, large B-Cell, diffuse
Recurrent Diffuse Large B-Cell Lymphoma
recurrence
Refractory Diffuse Large B-Cell Lymphoma
adult
gene therapy
immunotherapy, adoptive
lisocabtagene maraleucel
genetic therapy
---