Abecma(idecabtagene vicleucel)
Abecma (idecabtagene vicleucel) is a gene pharmaceutical. Idecabtagene vicleucel was first approved as Abecma on 2021-03-03. It is used to treat multiple myeloma in the USA. It has been approved in Europe to treat blood protein disorders, cardiovascular diseases, hematologic diseases, hemic and lymphatic diseases, and hemorrhagic disorders amongst others.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Abecma
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 |
|---|---|---|
| abecma | Biologic Licensing Application | 2024-01-04 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple myeloma | — | D009101 | C90.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
idecabtagene vicleucel, Abecma, Celgene Corporation, a Bristol-Myers Squibb Company | |||
| 2028-03-26 | Orphan excl. | ||
Patent Expiration
No data
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| Q2055 | Idecabtagene vicleucel, up to 460 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose |
Clinical
Clinical Trials
84 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 38 | 23 | 6 | 1 | 5 | 62 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | 1 | — | — | — | 2 |
| Plasma cell leukemia | D007952 | — | C90.1 | — | 2 | — | — | — | 2 |
| Leukemia | D007938 | — | C95 | 1 | 1 | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glycogen storage disease type ii | D006009 | Orphanet_365 | E74.02 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | — | — | — | — | 1 | 1 |
| B-cell lymphoma | D016393 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Idecabtagene vicleucel |
| INN | idecabtagene vicleucel |
| Description | Idecabtagene vicleucel, sold under the brand name Abecma, is a cell-based gene therapy to treat multiple myeloma.
|
| Classification | Gene |
| Drug class | Antineoplastic |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4298199 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | 8PX1X7UG4D (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Abecma – Bristol Myers Squibb
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Trends
PubMed Central
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Additional graphs summarizing 1,663 documents
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Safety
Black-box Warning
Black-box warning for: Abecma
Adverse Events
Top Adverse Reactions
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62 adverse events reported
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