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Brexucabtagene autoleucel

Generic Name
Brexucabtagene autoleucel
Brand Names
Tecartus
Drug Type
Biotech
Unique Ingredient Identifier
4MD2J2T8SJ

Overview

Mantle cell lymphoma is a heterogeneous sub-category of non-Hodgkin's lymphoma that can be classified as either an aggressive nodal or an indolent leukemic non-nodal variant. Despite the introduction of Bruton's tyrosine kinase (BTK) inhibitors such as ibrutinib and acalabrutinib, the prognosis for MCL patients remains poor and those that relapse following BTK inhibitor therapy have few treatment options. More recently, chimeric antigen receptor (CAR) T cell therapies have been developed that modify a patient's own T cells using viral transduction to bind to and destroy cancerous cells. These therapies differ in manufacturing methodology, viral vector, chimeric antigen choice, and the internal co-stimulatory domains of the chimeric antigen. Similar to axicabtagene ciloleucel, brexucabtagene autoleucel employs a murine anti-CD19 single-chain variable fragment (scFv) linked to internal CD28- and CD3ζ-derived co-stimulatory domains. However, the preparation of brexucabtagene autoleucel, previously referred to as KTE-X19, uses a method of T cell enrichment that decreases the prevalence of CD19-expressing tumour cells in the CAR T cell preparation. Brexucabtagene autoleucel was granted accelerated approval for the treatment of relapsed and refractory MCL by the FDA on July 24, 2020, and is currently available through Kite Pharma Inc. under the tradename TECARTUS.

Background

Mantle cell lymphoma is a heterogeneous sub-category of non-Hodgkin's lymphoma that can be classified as either an aggressive nodal or an indolent leukemic non-nodal variant. Despite the introduction of Bruton's tyrosine kinase (BTK) inhibitors such as ibrutinib and acalabrutinib, the prognosis for MCL patients remains poor and those that relapse following BTK inhibitor therapy have few treatment options. More recently, chimeric antigen receptor (CAR) T cell therapies have been developed that modify a patient's own T cells using viral transduction to bind to and destroy cancerous cells. These therapies differ in manufacturing methodology, viral vector, chimeric antigen choice, and the internal co-stimulatory domains of the chimeric antigen. Similar to axicabtagene ciloleucel, brexucabtagene autoleucel employs a murine anti-CD19 single-chain variable fragment (scFv) linked to internal CD28- and CD3ζ-derived co-stimulatory domains. However, the preparation of brexucabtagene autoleucel, previously referred to as KTE-X19, uses a method of T cell enrichment that decreases the prevalence of CD19-expressing tumour cells in the CAR T cell preparation. Brexucabtagene autoleucel was granted accelerated approval for the treatment of relapsed and refractory MCL by the FDA on July 24, 2020, and is currently available through Kite Pharma Inc. under the tradename TECARTUS.

Indication

Brexucabtagene autoleucel is a modified autologous chimeric antigen receptor (CAR) T cell immunotherapy indicated for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in adult patients. It is additionally indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Brexucabtagene autoleucel has been granted accelerated approval based on results from a single-arm, open-label, multicentre clinical trial; continued approval may be contingent on confirmatory trials.

Associated Conditions

  • Refractory Mantle Cell Lymphoma
  • Relapsed Mantle Cell Lymphoma
  • Refractory B-cell precursor acute lymphoblastic leukemia
  • Relapsed B cell precursor Acute lymphoblastic leukemia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/08/14
Phase 2
Recruiting
2024/07/01
Phase 2
Recruiting
Christian Schmidt, MD
2024/02/12
Phase 2
Recruiting
2023/11/22
Phase 2
Recruiting
2023/03/20
N/A
AVAILABLE
2022/09/13
Phase 2
Terminated
2021/09/13
Phase 2
ENROLLING_BY_INVITATION
2021/05/10
Phase 2
Active, not recruiting
2018/08/22
Phase 2
Active, not recruiting
2015/11/25
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
T Cells - Brexucabtagene autoleucel, cryopreserved - T - Tecartus
396794
Biological
A
9/30/2022
T Cells - Brexucabtagene autoleucel, cryopreserved - T - Tecartus
371431
Biological
A
7/21/2021
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