NAV

Idecabtagene vicleucel

Identification

Summary

Idecabtagene vicleucel is 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.2 These cancerous cells generally express the B-cell maturation antigen, while it is rarely expressed on non-cancerous cells.2 Multiple myeloma is typically treated with an immunomodulatory agent like lenalidomide,6 a proteasome inhibitor like bortezomib, or an anti-CD38 monoclonal antibody like isatuximab.8

Idecabtagene vicleucel, also known as bb2121, is a chimeric antigen receptor (CAR) T-cell therapy like axicabtagene ciloleucel and brexucabtagene autoleucel.1,2,9 These therapies involve extracting and genetically manipulating T-cells from a patient to express a CAR for a tumor specific antigen.1 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.9 Idecabtagene vicleucel is indicated as a fifth line treatment of adult patients with relapsed or refractory multiple myeloma.9

Idecabtagene vicleucel was granted FDA approval on 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
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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
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Treatment ofRefractory multiple myeloma••••••••••••••••••••••••• ••••••••• •••••••••• •••••••• •••••••••• •••••••• •••••••••••••••• ••••• •••••••••• •••••••• •••••••••• ••••••••• •••••••••• •• ••••• ••••• •• •••••••••••••••
Treatment ofRelapsed multiple myeloma••••••••••••••••••••••••• •••••••••••••••• ••••• •••••••••• •••••••• ••••••••• •••••••••• •••••••• •••••••••• •• ••••• ••••• •• •••••••• •••••••• •••••••••• ••••••••• •••••••••••••••••
Contraindications & Blackbox Warnings
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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.9 It has a long duration of action as expansion takes place over days.9 Patients 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.2 These 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.9 The single chain variable fragment (scFv) allows for B-cell maturation antigen specificity of the CAR.5,9 The CD23ζ cytoplasmic domain mediates T-cell activation by CD2, a T-cell surface adhesion molecule.3 4-1BB enhances cytotoxic T-cell activity as well as the production of interferon-γ.4

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

TargetActionsOrganism
ATumor necrosis factor receptor superfamily member 17
binder
Humans
Absorption

Idecabtagene vicleucel reaches a geometric mean Cmax of 256,333 copies/µg, with a median Tmax of 11 days, and a geometric mean AUC0-28 days of 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.9 However, patients experiencing an overdose may experience and increased risk and severity of adverse effects including cytokine release syndrome, infection, fatigue, and musculoskeletal pain.9 Patients should be treated with symptomatic and supportive measures.

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

Interactions

Drug Interactions Learn More" title="About Drug Interactions" id="structured-interactions-info" class="drug-info-popup" href="javascript:void(0);">
This information should not be interpreted without 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.
DrugInteraction
Integrate drug-drug
interactions in your software
AmbroxolThe risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Ambroxol.
ArticaineThe risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Articaine.
BenzocaineThe risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Benzocaine.
Benzyl alcoholThe risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Benzyl alcohol.
BupivacaineThe risk or severity of methemoglobinemia can be increased when Idecabtagene vicleucel is combined with Bupivacaine.
Food Interactions
No interactions found.

Products

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International/Other Brands
Abecma (Bristol Myers Squibb; Bluebird Bio, Inc.)
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
AbecmaSuspension300000000 1/1IntravenousCelgene Corporation2021-03-26Not applicableUS flag
AbecmaSuspension380000000 cellsIntravenousBristol Myers Squibb Pharma Eeig2021-10-07Not applicableEU flag
AbecmaSuspension520000000 cellsIntravenousCelgeneNot applicableNot applicableCanada 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 Trials Learn More" title="About Clinical Trials" id="clinical-trials-info" class="drug-info-popup" href="javascript:void(0);">
PhaseStatusPurposeConditionsCount
3Active Not RecruitingTreatmentMultiple Myeloma (MM)1
3RecruitingTreatmentMultiple Myeloma (MM)1
2Active Not RecruitingTreatmentMultiple Myeloma (MM)1
2CompletedTreatmentMultiple Myeloma (MM)1
2RecruitingTreatmentMultiple Myeloma (MM)2

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
SuspensionIntravenous300000000 1/1
SuspensionIntravenous380000000 cells
SuspensionIntravenous520000000 cells
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Targets

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Details1. 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
Molecular Weight
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