NAV

Idecabtagene vicleucel

Identification

Summary

Idecabtagene vicleucelis an autologous T-cell therapy indicated to treat relapsed or refractory multiple myeloma.

Brand Names
Abecma
Generic Name
Idecabtagene vicleucel
DrugBank Accession Number
DB16665
Background

Multiple myeloma is a cancer where plasma cells rapidly divide out of control.2These cancerous cells generally express the B-cell maturation antigen, while it is rarely expressed on non-cancerous cells.2Multiple myeloma is typically treated with an immunomodulatory agent likelenalidomide,6a proteasome inhibitor likebortezomib, or an anti-CD38 monoclonal antibody likeisatuximab.8

Idecabtagene vicleucel, also known as bb2121, is a chimeric antigen receptor (CAR) T-cell therapy likeaxicabtagene ciloleucelandbrexucabtagene autoleucel.1,2,9These therapies involve extracting and genetically manipulating T-cells from a patient to express a CAR for a tumor specific antigen.1The chimeric antigen receptor of idecabtagene vicleucel includes an anti-B-cell maturation antigen scFv-targeting domain, CD3ζ T-cell activation domain, and 4-1BB costimulatory domain.9Idecabtagene vicleucel is indicated as a fifth line treatment of adult patients with relapsed or refractory multiple myeloma.9

Idecabtagene vicleucel获得FDA的批准26 March 2021.10

Type
Biotech
Groups
Approved
Biologic Classification
Cell transplant therapies
Autologous cell transplant
Synonyms
  • Anti-BCMA CAR T cell
  • IDE-CEL
  • Idecabtagene vicleucel
External IDs
  • BB 2121
  • BB-2121
  • BB2121

Pharmacology

Indication

Idecabtagene vicleucel is indicated to treat adult patients with relapsed or refractory multiple myeloma who have tried at least 4 other lines of therapy, including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 monoclonal antibody.9

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Associated Conditions
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Pharmacodynamics

Idecabtagene vicleucel is a B-cell maturation antigen directed chimeric antigen receptor T-cell therapy indicated to treat relapsed or refractory multiple myeloma.9It has a long duration of action as expansion takes place over days.9Patients should be counselled regarding the risk of hypersensitivity, infection, prolonged cytopenias, hypogammaglobulinemia, secondary malignancies, and to avoid driving for at least 8 weeks after treatment.9

Mechanism of action

Multiple myeloma is a cancer where plasma cells rapidly divide out of control.2These cancerous cells generally express the B-cell maturation antigen, while it is rarely expressed on non-cancerous cells.2

The chimeric antigen receptor of idecabtagene vicleucel includes an anti-B-cell maturation antigen scFv-targeting domain, CD3ζ T-cell activation domain, and 4-1BB costimulatory domain.9The single chain variable fragment (scFv) allows for B-cell maturation antigen specificity of the CAR.5,9The CD23ζ cytoplasmic domain mediates T-cell activation by CD2, a T-cell surface adhesion molecule.34-1BB enhances cytotoxic T-cell activity as well as the production of interferon-γ.4

Idecabtagene vicleucel binds to B-cell maturation antigen expressing cells.9Binding to the target leads to proliferation of idecabtagene vicleucel, secretion of cytokines, and lysis of the targeted cells.9

Target Actions Organism
ATumor necrosis factor receptor superfamily member 17
binder
 Humans
Absorption

Idecabtagene vicleucel reaches a geometric mean Cmax256333本/µg,with a median Tmaxof 11 days, and a geometric mean AUC0-28 daysof 3,088,455 days*copies/µg.9

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
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Toxicity

Data regarding overdose of idecabtagene vicleucel is not readily available.9However, patients experiencing an overdose may experience and increased risk and severity of adverse effects including cytokine release syndrome, infection, fatigue, and musculoskeletal pain.9Patients should be treated with symptomatic and supportive measures.

Pathways
Not Available
Pharmacogenomic Effects/ADRsBrowse all" title="" id="snp-actions-info" class="drug-info-popup" href="javascript:void(0);">
Not Available

Interactions

Drug InteractionsLearn More" title="" id="structured-interactions-info" class="drug-info-popup" href="javascript:void(0);">
这些信息不应该被解释the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction
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interactions in your software
Ambroxol The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Ambroxol.
Articaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Articaine.
Benzocaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Benzocaine.
Benzyl alcohol The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Benzyl alcohol.
Bupivacaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Bupivacaine.
Butacaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Butacaine.
Butamben The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Butamben.
Capsaicin The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Capsaicin.
Chloroprocaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Chloroprocaine.
Cinchocaine The risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Cinchocaine.
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Food Interactions
No interactions found.

Products

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International/Other Brands
Abecma (Bristol Myers Squibb; Bluebird Bio, Inc.)
Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image
Abecma Suspension 380000000 cells Intravenous Bristol Myers Squibb Pharma Eeig 2021-10-07 Not applicable EU flag
Abecma Suspension 520000000 cells Intravenous Celgene Not applicable Not applicable Canada flag
Abecma Suspension 300000000 1/1 Intravenous Celgene Corporation 2021-03-26 Not applicable US flag

Categories

ATC Codes
L01XL07 — Idecabtagene vicleucel
Drug Categories
Classification
Not classified
Affected organisms
Not Available

Chemical Identifiers

UNII
8PX1X7UG4D
CAS number
Not Available

References

General References
  1. Marzal-Alfaro MB, Escudero-Vilaplana V, Revuelta-Herrero JL, Collado-Borrell R, Herranz-Alonso A, Sanjurjo-Saez M: Chimeric Antigen Receptor T Cell Therapy Management and Safety: A Practical Tool From a Multidisciplinary Team Perspective. Front Oncol. 2021 Mar 11;11:636068. doi: 10.3389/fonc.2021.636068. eCollection 2021. [Article]
  2. Abramson HN: B-Cell Maturation Antigen (BCMA) as a Target for New Drug Development in Relapsed and/or Refractory Multiple Myeloma. Int J Mol Sci. 2020 Jul 22;21(15). pii: ijms21155192. doi: 10.3390/ijms21155192. [Article]
  3. Howard FD, Moingeon P, Moebius U, McConkey DJ, Yandava B, Gennert TE, Reinherz EL: The CD3 zeta cytoplasmic domain mediates CD2-induced T cell activation. J Exp Med. 1992 Jul 1;176(1):139-45. doi: 10.1084/jem.176.1.139. [Article]
  4. Vinay DS, Kwon BS: 4-1BB (CD137), an inducible costimulatory receptor, as a specific target for cancer therapy. BMB Rep. 2014 Mar;47(3):122-9. doi: 10.5483/bmbrep.2014.47.3.283. [Article]
  5. Ahmad ZA, Yeap SK, Ali AM, Ho WY, Alitheen NB, Hamid M: scFv antibody: principles and clinical application. Clin Dev Immunol. 2012;2012:980250. doi: 10.1155/2012/980250. Epub 2012 Mar 15. [Article]
  6. Tageja N: Lenalidomide - current understanding of mechanistic properties. Anticancer Agents Med Chem. 2011 Mar;11(3):315-26. doi: 10.2174/187152011795347487. [Article]
  7. Okazuka K, Ishida T: Proteasome inhibitors for multiple myeloma. Jpn J Clin Oncol. 2018 Sep 1;48(9):785-793. doi: 10.1093/jjco/hyy108. [Article]
  8. Gandhi UH, Cornell RF, Lakshman A, Gahvari ZJ, McGehee E, Jagosky MH, Gupta R, Varnado W, Fiala MA, Chhabra S, Malek E, Mansour J, Paul B, Barnstead A, Kodali S, Neppalli A, Liedtke M, Narayana S, Godby KN, Kang Y, Kansagra A, Umyarova E, Scott EC, Hari P, Vij R, Usmani SZ, Callander NS, Kumar SK, Costa LJ: Outcomes of patients with multiple myeloma refractory to CD38-targeted monoclonal antibody therapy. Leukemia. 2019 Sep;33(9):2266-2275. doi: 10.1038/s41375-019-0435-7. Epub 2019 Mar 11. [Article]
  9. FDA Approved Drug Products: Abecma (Idecabtagene Vicleucel) Intravenous Infusion [Link]
  10. FDA Approval Letter: Idecabtagene Vicleucel [Link]
RxNav
2536430
Wikipedia
Idecabtagene_vicleucel

Clinical Trials

Clinical TrialsLearn More" title="" id="clinical-trials-info" class="drug-info-popup" href="javascript:void(0);">
Phase Status Purpose Conditions Count
3 Active Not Recruiting Treatment Multiple Myeloma (MM) 1
2 Active Not Recruiting Treatment Multiple Myeloma (MM) 1
2 Recruiting Treatment Multiple Myeloma (MM) 3
1 Active Not Recruiting Treatment Multiple Myeloma (MM) 1
1 Completed Treatment Multiple Myeloma (MM) 1
1, 2 Recruiting Treatment Multiple Myeloma (MM) 1
0 Not Yet Recruiting Treatment Multiple Myeloma (MM) 1
Not Available Available Not Available Multiple Myeloma (MM) 1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
Form Route Strength
Suspension Intravenous 300000000 1/1
Suspension Intravenous 380000000 cells
Suspension Intravenous 520000000 cells
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Targets

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Details 1.Tumor necrosis factor receptor superfamily member 17
Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Binder
General Function
Receptor for TNFSF13B/BLyS/BAFF and TNFSF13/APRIL. Promotes B-cell survival and plays a role in the regulation of humoral immunity. Activates NF-kappa-B and JNK.
Specific Function
Signaling receptor activity
Gene Name
TNFRSF17
Uniprot ID
Q02223
Uniprot Name
Tumor necrosis factor receptor superfamily member 17
分子量
20165.065 Da
References
  1. FDA Approved Drug Products: Abecma (Idecabtagene Vicleucel) Intravenous Infusion [Link]

Drug created at March 31, 2021 15:46 / Updated at March 31, 2021 22:11