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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 acer, blood protein disorders, cardiovascular diseases, hematologic diseases, and hemic and lymphatic diseases amongst others.
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Case Study: Multiple Myeloma
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
immune system diseasesD007154
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)
Idecabtagene vicleucel
Tradename
Proper name
Company
Number
Date
Products
Abecmaidecabtagene vicleucelCelgeneN-125736 RX2021-03-03
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
abecmaBiologic Licensing Application2021-03-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
multiple myeloma—D009101C90.0
Agency Specific
FDA
EMA
Expiration
Code
idecabtagene vicleucel, Abecma, Celgene Corporation, a Bristol-Myers Squibb Company
2028-03-26Orphan 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
20 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101C90.01171—118
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C9511———1
LymphomaD008223C85.911———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0————11
B-cell lymphomaD016393————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIDECABTAGENE VICLEUCEL
INNidecabtagene vicleucel
Description
Idecabtagene vicleucel, sold under the brand name Abecma, is a cell-based gene therapy to treat multiple myeloma.
Classification
Gene
Drug classAntineoplastic
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4298199
ChEBI ID—
PubChem CID—
DrugBank—
UNII ID8PX1X7UG4D (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Abecma - 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 743 documents
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Safety
Black-box Warning
Black-box warning for: Abecma
Adverse Events
Top Adverse Reactions
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43,888 adverse events reported
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