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
Therapeutic Areas
Trade Name
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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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| breyanzi | Biologic Licensing Application | 2024-05-30 |
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
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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
25 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 7 | 12 | 4 | — | 1 | 20 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 4 | 10 | 2 | — | 2 | 15 |
| B-cell lymphoma | D016393 | — | — | 5 | 9 | 2 | — | 1 | 15 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 5 | 7 | 1 | — | 2 | 13 |
| Follicular lymphoma | D008224 | — | C82 | 4 | 3 | 1 | — | 2 | 9 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | 3 | 1 | — | 2 | 6 |
| Leukemia | D007938 | — | C95 | 2 | 4 | 1 | — | — | 5 |
| Lymphoid leukemia | D007945 | — | C91 | 2 | 4 | 1 | — | — | 5 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cytokine release syndrome | D000080424 | — | D89.83 | — | 1 | — | — | 1 | 2 |
| Neoplasms | D009369 | — | C80 | 1 | 2 | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 1 | 1 | — | — | 1 | 2 |
| Aggression | D000374 | EFO_0003015 | — | — | 2 | — | — | — | 2 |
| Recurrence | D012008 | — | — | 1 | 1 | — | — | — | 2 |
| Neurotoxicity syndromes | D020258 | — | G92 | — | 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 |
| Lymphatic diseases | D008206 | HP_0100763 | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mantle-cell lymphoma | D020522 | — | — | 1 | — | — | — | 1 | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | — | — | — | — | 3 | 3 |
| Myocarditis | D009205 | — | I51.4 | — | — | — | — | 1 | 1 |
| Adoptive immunotherapy | D016219 | — | — | — | — | — | — | 1 | 1 |
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 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
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Variants
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Financial
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Breyanzi – Bristol Myers Squibb
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Trends
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Additional graphs summarizing 1,736 documents
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Safety
Black-box Warning
Black-box warning for: Breyanzi
Adverse Events
Top Adverse Reactions
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461 adverse events reported
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