Breyanzi (lisocabtagene maraleucel) · Juno Therapeutics, Inc. a Bristol Myer-Squibb Company
BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: • adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: • refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line ch...
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
9 indicationsBreyanzi is approved for 9 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Large B-Cell Lymphoma
- Diffuse Large B-Cell Lymphoma
- High-Grade B-Cell Lymphoma
- Primary Mediastinal Large B-Cell Lymphoma
- Follicular Lymphoma
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Mantle Cell Lymphoma
- Marginal Zone Lymphoma
Breyanzi 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 BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids [see Dosage and Administration ( 2.2 , 2.3 ) and Warnings and Precautions ( 5.1 )] . • Neurologic toxicities, in...
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids [see Dosage and Administration ( 2.2 , 2.3 ) and Warnings and Precautions ( 5.1 )] . • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed [see Dosage and Administration ( 2.2 , 2.3 ) and 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 BREYANZI [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 BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids. ( 2.2 , 2.3 , 5.1 ) • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed. ( 2.2 , 2.3 , 5.2 ) • T cell malignancies have occurred following treatment of hematologic malignanc
Breyanzi 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.
Breyanzi Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in Breyanzi's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications Breyanzi treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to Breyanzi
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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
Indications & Usage
BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: • adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: • refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or • refractory disease to first-line chemoimmunotherapy or relapse after first-li...
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory ...
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
- • 20 similar drugs
- • 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.