TheraRadar
Data updated: Jul 17, 2026

Kymriah (tisagenlecleucel) · Novartis

Approved 2017-08-29
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2017-08-29
Patent Cliff
2029
Revenue
$143M (Q4-2021)

Pro Metrics

Patent cliff and revenue data

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Routes
Intravenous
Dosage Forms
Injection

Companies

Novartis
Active Ingredient: tisagenlecleucel

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 approvals

Originally approved for its first indication in 2017 .

  • Other (1)

Kymriah Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

8

Same target(s), different indications — where else is this mechanism being explored?

Aucatzyl
Autolus, Inc.
2024
ZYNLONTA
ADC Therapeutics
2021 3 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

19 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
NCT07676877 OSU-25255 NCI-2026-04299 Ph 1 not yet recruiting Lymphodepletion With Low Dose Total Body Irradiation Before Standard of Care Tisagenlecleucel for the Treatment of Relapsed and Recurrent Large B-cell 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.

Kymriah FDA Label Details

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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
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Data Sources

FDA Approval: BLA125646 → Trials: ClinicalTrials.gov →

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