Breyanzi(lisocabtagene maraleucel)
Breyanzi (lisocabtagene maraleucel) is a gene pharmaceutical. Lisocabtagene maraleucel was first approved as Breyanzi on 2021-02-05. It is used to treat b-cell lymphoma in the USA. It has been approved in Europe to treat follicular lymphoma, large b-cell lymphoma diffuse, and mediastinal neoplasms.
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Commercial
Trade Name
FDA
EMA
Breyanzi
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Lisocabtagene maraleucel
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Breyanzi | lisocabtagene maraleucel | Celgene | A-125714 RX | 2021-02-05 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| breyanzi | Biologic Licensing Application | 2021-02-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| b-cell lymphoma | — | D016393 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
lisocabtagene maraleucel, Breyanzi, Juno Therapeutics, Inc. a Bristol Myer-Squibb Company | |||
| 2029-06-24 | Orphan excl. | ||
Patent Expiration
No data
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| Q2054 | Lisocabtagene maraleucel, up to 110 million autologous anti-cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
Clinical
Clinical Trials
19 clinical trials
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Indications Phases 4
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 5 | 5 | — | — | 2 | 11 | |
| Follicular lymphoma | D008224 | C82 | 4 | 3 | — | — | 1 | 7 | |
| B-cell lymphoma | D016393 | 1 | 3 | — | — | 1 | 5 | ||
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | 2 | — | — | 1 | 3 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | 1 | — | — | 1 | 2 | |
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Lymphoma | D008223 | C85.9 | — | 1 | — | — | — | 1 | |
| Immune system diseases | D007154 | D89.9 | — | 1 | — | — | — | 1 | |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | — | 1 | — | — | — | 1 |
| Neoplasms by histologic type | D009370 | — | 1 | — | — | — | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | LISOCABTAGENE MARALEUCEL |
| INN | lisocabtagene maraleucel |
| Description | Lisocabtagene maraleucel, sold under the brand name Breyanzi, is a cell-based gene therapy used to treat large B-cell lymphoma.
|
| Classification | Gene |
| Drug class | Antineoplastic |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297236 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16582 |
| UNII ID | 7K2YOJ14X0 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Breyanzi - Bristol Myers Squibb
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 921 documents
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Safety
Black-box Warning
Black-box warning for: Breyanzi
Adverse Events
Top Adverse Reactions
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3,383 adverse events reported
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