TheraRadar
Data updated: May 26, 2026

Tecartus (brexucabtagene autoleucel)

Approved 2020-07-23
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
5
Years on Market

Details

Status
Prescription
First Approved
2020-07-23
Patent Cliff
2028

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Routes
Intravenous
Dosage Forms
For Injection

Companies

Gilead Sciences
Active Ingredient: Brexucabtagene Autoleucel

Tecartus Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2020 to 2020
Jul 2020 ORIGINAL
Update · CBER biologic (Purple Book)

What Tecartus Treats

1 FDA approvals

Originally approved for its first indication in 2020 .

  • Other (1)
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Clinical Trial Registry

8 trials
Trial Sponsor ID Phase Status Title
NCT06144606 MCC-22286 Ph 2 recruiting Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)
NCT06553872 MCC-22557 J2N-US-I010 Ph 2 recruiting Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL
NCT02601313 ZUMA-2 results posted KTE-C19-102 2015-005008-27, 2023-506641-35 Ph 2 completed Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
NCT05537766 ZUMA-25 results posted KT-US-568-0138 2022-501259-10, 2022-501260-18 Ph 2 terminated Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies
NCT03642626 results posted 2017LS118 MT2017-45, NCI-2020-04527 Ph 2 active not recruiting MT2017-45: CAR-T Cell Therapy for Heme Malignancies
NCT04880434 ZUMA-2 KTE-C19-102 (Cohort 3) 2015-005008-27 Ph 2 completed Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)
NCT02614066 ZUMA-3 results posted KTE-C19-103 2015-005009-35 Ph 1, Ph 2 completed A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)
NCT03624036 ZUMA-8 results posted KTE-C19-108 2018-001923-38 Ph 1 terminated Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

Tecartus FDA Label Details

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Data Sources

FDA Approval: BLA125703 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.