Data updated: May 26, 2026
Kymriah (tisagenlecleucel)
Approved 2017-08-29
1
Indication
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Prescription
- First Approved
- 2017-08-29
- Patent Cliff
- 2029
- Revenue
- $143M (Q4-2021)
- Routes
- Intravenous
- Dosage Forms
- Injection
Kymriah 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
Aug 2017 ORIGINAL
Update · CBER biologic (Purple Book)
What Kymriah Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
Other
(1 approval)- • Approved indication (Aug 2017)
📋
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05888493 LEDA | CCTL019E2301 2023-503452-27-00 | Ph 3 | active not recruiting | A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma |
| NCT06408194 | IRB-74214 NCI-2024-04331 | Ph 1 | recruiting | Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies |
| NCT05460533 | 22-220 | Ph 2 | active not recruiting | A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL) |
| 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 |
| 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 |
| NCT04134117 | 19-319 | Ph 1 | completed | Tisagenlecleucel In Primary CNS Lymphoma |
| NCT05075603 | NIT-112 | Ph 1 | completed | Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy |
| NCT03568461 ELARA results posted | CCTL019E2202 2017-004385-94, 2023-508127-13-00 | Ph 2 | completed | Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma |
| NCT03610724 BIANCA results posted | CCTL019C2202 2017-005019-15 | Ph 2 | completed | Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients |
| NCT02445248 JULIET results posted | CCTL019C2201 2014-003060-20 | Ph 2 | completed | Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients |
| NCT04156659 | CCTL019B2210 | Ph 2 | withdrawn | Study of Tisagenlecleucel in Chinese Pediatric and Young Adult Subjects With Relapsed or Refractory B-cell ALL |
| NCT03876028 | CCTL019L12101C | Ph 1 | terminated | Study of Tisagenlecleucel in Combination With Ibrutinib in r/r Diffuse Large B-cell Lymphoma Patients |
| NCT04225676 results posted | CCTL019BUS03 | Ph 2 | terminated | Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL) |
| NCT03630159 PORTIA | CCTL019J2101 2018-000973-57 | Ph 1 | completed | Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients |
| NCT02529813 | 2013-1018 NCI-2015-01492, 20152145 | Ph 1 | completed | CD19-Specific T-cells in Treating Patients With Advanced Lymphoid Malignancies |
| NCT04456023 | CCTL019C2203 | Ph 2 | withdrawn | Study of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphoma (DLBCL) |
| NCT03628053 OBERON | CCTL019I2301 | Ph 3 | withdrawn | Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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.
Kymriah FDA Label Details
Pro Intelligence Preview
Deep insights for Kymriah
Revenue Insights
- • Q4-2021: $143M
- • 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
Unlock Full Intelligence
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.