Breyanzi (lisocabtagene maraleucel) · Juno Therapeutics, Inc. a Bristol Myer-Squibb Company
Details
- Status
- Prescription
- First Approved
- 2021-02-04
- Patent Cliff
- 2033
- Revenue
- $392M (Q4-2025)
- Routes
- Intravenous
- Dosage Forms
- Injection
Breyanzi Approval History
What Breyanzi Treats
1 FDA approvalsOriginally approved for its first indication in 2021 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 2021)
Breyanzi 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.
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 | active not 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) |
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.
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
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.