Yescarta (axicabtagene ciloleucel) · Gilead Sciences
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma,...
Details
- Status
- Prescription
- First Approved
- 2017-10-17
- Patent Cliff
- 2029
- Revenue
- $368M (Q4-2025)
- Routes
- Intravenous
- Dosage Forms
- Injection
Yescarta Approval History
What Yescarta Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
Other
(1 approval)- • Approved indication (Oct 2017)
Yescarta Boxed Warning
CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.1) ] . Neurologic toxicities, including...
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.1) ] . Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.2) ] . T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA [see Warnings and Precautions (5.7) ] . WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES See full prescribing information for complete boxed warning . Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids ( 2.2 , 2.3 , 5.1 ). Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids, as needed ( 2.2 , 2.3 , 5.2 ). T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified aut
Yescarta Target & Pathway
ProTarget
A protein expressed on B-cells throughout their development. CD19 is a key target for CAR-T cell therapies in B-cell leukemias and lymphomas, where engineered T-cells are directed to kill CD19-expressing cancer cells.
Yescarta Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Gilead Sciences's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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 results posted | 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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Indications & Usage
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Adult patients with relapse...
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory dis...
Pro Intelligence Preview
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
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.