Data updated: May 26, 2026
Breyanzi (lisocabtagene maraleucel)
Approved 2021-02-04
1
Indication
--
Phase 3 Trials
5
Years on Market
Details
- Status
- Prescription
- First Approved
- 2021-02-04
- Patent Cliff
- 2033
- Revenue
- $392M (Q4-2025)
- Routes
- Intravenous
- Dosage Forms
- Injection
Breyanzi Approval History
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2021 to 2021
Feb 2021 ORIGINAL
Update · CBER biologic (Purple Book)
What Breyanzi Treats
1 FDA approvalsOriginally approved for its first indication in 2021 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 2021)
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Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07194980 | RG1125624 NCI-2025-06406, 20853 | Ph 2 | recruiting | Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| NCT05359211 | RG1122036 NCI-2022-02316, 10802 | Ph 1 | active not recruiting | NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma |
| NCT07188558 PiNACLE-H2H | LYL314-102 | Ph 3 | recruiting | A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy |
| NCT05873712 | OSU-22157 NCI-2023-03669 | Ph 2 | recruiting | Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome |
| 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 |
| NCT05583149 results posted | 21-422 | Ph 2 | active not recruiting | Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas |
| NCT07098364 | RG1125654 NCI-2025-04890, 20817 | Ph 1, Ph 2 | recruiting | ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed/Refractory Large B-Cell Lymphoma |
| NCT05672173 | 22040 NCI-2022-10247, 22040 | Ph 2 | recruiting | Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation |
| NCT05075603 | NIT-112 | Ph 1 | completed | Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy |
| NCT03744676 results posted | 017007 | Ph 2 | completed | A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007) |
| NCT03483103 results posted | 017006 | Ph 2 | completed | Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006) |
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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.
Breyanzi FDA Label Details
Pro Intelligence Preview
Deep insights for Breyanzi
Revenue Insights
- • Q4-2025: $392M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 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.