Data updated: May 26, 2026
Yescarta (axicabtagene ciloleucel)
Approved 2017-10-17
1
Indication
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Prescription
- First Approved
- 2017-10-17
- Patent Cliff
- 2029
- Revenue
- $368M (Q4-2025)
- Routes
- Intravenous
- Dosage Forms
- Injection
Yescarta Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2017 to 2017
Oct 2017 ORIGINAL
Update · CBER biologic (Purple Book)
What Yescarta Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
Other
(1 approval)- • Approved indication (Oct 2017)
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Clinical Trial Registry
35 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07538635 CAR-T+ASCT | CAR-T+ASCT No ID | Ph 2 | recruiting | CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors. |
| NCT07479797 | KT-US-740-0603 2025-524403-80-00 | Ph 3 | recruiting | Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy |
| NCT06043323 | 2023-0087 NCI-2023-07173 | Ph 2 | recruiting | A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma |
| NCT05605899 ZUMA-23 | KT-US-484-0136 2022-501489-24-00 | Ph 3 | active not recruiting | Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma |
| NCT05077527 | AMC-112 NCI-2021-02771, AMC-112 | Ph 1 | recruiting | Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma |
| NCT04531046 | ALYCANTE | Ph 2 | active not recruiting | Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation |
| 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) |
| NCT07042438 | 24910 NCI-2025-03771, 24910 | Ph 2 | recruiting | Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Exposure to High-Risk Antibiotics Who Are Receiving Chimeric Antigen Receptor T Cells |
| NCT07188558 PiNACLE-H2H | LYL314-102 | Ph 3 | recruiting | A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy |
| NCT04205838 | 19-000604 NCI-2019-02887, 19-000604 | Ph 2 | terminated | Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma |
| NCT05633615 | S2114 NCI-2022-07930, S2114 | Ph 2 | recruiting | Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma |
| NCT05459571 ZUMA-24 | KT-US-482-0137 | Ph 2 | completed | Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma |
| NCT03642626 results posted | 2017LS118 MT2017-45, NCI-2020-04527 | Ph 2 | active not recruiting | MT2017-45: CAR-T Cell Therapy for Heme Malignancies |
| NCT04855253 | 2020LS100 MT2020-27 | Ph 1, Ph 2 | suspended | Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL |
| NCT07326371 | Glofit_peri_CART | Ph 2 | not yet recruiting | Glofitamab Combined With CAR-T Therapy in R/R DLBCL |
| NCT03105336 ZUMA-5 results posted | KTE-C19-105 2017-001912-13, 2023-505169-10 | Ph 2 | completed | A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma |
| NCT03391466 ZUMA-7 results posted | KTE-C19-107 2017-002261-22 | Ph 3 | completed | Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma |
| NCT07254754 LATE-R-GEL-23 | LATE-R-GEL-23 | Ph 2 | recruiting | Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma |
| NCT04150913 results posted | 19-348 | Ph 2 | completed | A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity |
| NCT06550141 | 24-317 | Ph 2 | recruiting | Emapalumab Prevention of CAR-T Cell Associated Toxicities |
| NCT05075603 | NIT-112 | Ph 1 | completed | Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy |
| NCT05371093 ZUMA-22 | KT-US-473-0133 2021-003260-28, 2024-511594-30 | Ph 3 | active not recruiting | Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma |
| NCT04257578 | RG1006269 NCI-2020-00238, 10418 | Ph 1, Ph 2 | active not recruiting | Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma |
| NCT05794958 | IRB-68723 CCT5068, NCI-2023-05593 | Ph 1 | recruiting | Evaluate Safety of Axicabtagene Ciloleucel Reinfusion (Axi-Cel-2) in Patients With Relapsed and/or Refractory Second Line High-Risk Non-Hodgkin Lymphoma After Standard of Care Axi-Cel |
| NCT04608487 | 20-274 | Ph 1 | active not recruiting | Axi-cel in CNS Lymphoma |
| NCT05108805 results posted | VICC CTT 2109 | Ph 4 | completed | Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting |
| NCT06826118 | XMDYYYXYK-16 | Ph 2 | recruiting | Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma |
| NCT04432506 results posted | 2019-1051 NCI-2020-04369, 2019-1051 | Ph 2 | completed | Anakinra for the Reduction of CAR-T Toxicity in Patients With Relapsed or Refractory Large B-cell Lymphoma |
| NCT03761056 ZUMA-12 results posted | KTE-C19-112 2019-002291-13 | Ph 2 | completed | Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma |
| NCT06609304 axi-cel | TA2024-252 | Ph 4 | recruiting | Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma |
| NCT03704298 ZUMA-11 results posted | KTE-C19-111 | Ph 1 | terminated | Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma |
| NCT02348216 ZUMA-1 results posted | KTE-C19-101 2015-005007-86 | Ph 1, Ph 2 | completed | Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma |
| NCT04071366 results posted | INCB 39110-211 | Ph 2 | completed | A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy |
| NCT04314843 ZUMA-19 results posted | KT-US-471-0119 2019-004568-23 | Ph 1 | terminated | Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma |
| NCT04002401 ZUMA-14 results posted | KT-US-471-0114 2019-004803-11 | Ph 2 | completed | Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
Yescarta FDA Label Details
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Deep insights for Yescarta
Revenue Insights
- • Q4-2025: $368M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.