Also known as: Breyanzi
Liso-cel (lisocabtagene maraleucel) is a CD19-directed CAR-T cell therapy marketed as Breyanzi for relapsed or refractory B-cell malignancies. It is used in adult patients with large B-cell lymphoma and additional indications such as CLL/SLL, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma. The FDA first approved Breyanzi in 2021, with subsequent label expansions.
The FDA approved Bristol Myers Squibb’s Breyanzi for adults with relapsed or refractory marginal zone lymphoma after at least two prior systemic therapies. In TRANSCEND FL, the CAR T therapy showed a 95.5% overall response rate and 62.1% complete response rate.
Bristol Myers Squibb said 2025 revenue was flat as a 17% increase in growth-portfolio sales offset a 15% decline in legacy drugs. The company expects legacy sales to fall another 12-16% in 2026, with newer products such as Opdivo, Reblozyl and Breyanzi supporting results.
The 2026 Tandem Meetings featured new data on CAR-T, allogeneic transplantation, and supportive care. Highlights included early efficacy signals for EB-103, KITE-753, Orca-T, and NXC-201, plus comparative cardiovascular safety data for lisocabtagene maraleucel.
The cell therapy manufacturing market is projected to reach $14.01 billion by 2035, with CAR-T therapies dominating at 65% market share. Recent FDA approvals for new CAR-T indications and Japanese regulatory acceleration highlight growing clinical adoption, while research advances include new anti-aging protein platforms and CRISPR-based treatments.
The FDA has approved Bristol Myers Squibb's CAR-T therapy Breyanzi for relapsed/refractory marginal zone lymphoma, while a novel multiple myeloma drug candidate DTP3 advances to Phase 2 trials after showing promising early results. Both developments represent significant progress in blood cancer treatment, with the marginal zone lymphoma approval based on a 95.5% response rate and the myeloma drug demonstrating selective cancer cell killing without toxicity.
New market reports forecast significant expansion in CAR T-cell therapy, US pharmaceutical drug delivery, and healthcare nanotechnology sectors, driven by chronic disease prevalence and technological advances.
Healthcare sector surged 10% since Q4 2025, outpacing all S&P 500 sectors as investors rotate from tech to pharmaceutical value plays. Major drugmakers demonstrate resilience following Medicare price negotiations implementation.
Citius Pharmaceuticals reported $3.9 million in first revenue from LYMPHIR's December 2025 launch for cutaneous T-cell lymphoma, while subsidiary Citius Oncology announced positive Phase 1 data showing 86% response rate when LYMPHIR was administered prior to CAR-T therapy in high-risk lymphoma patients.
Bristol Myers Squibb's growth portfolio increased 17% in 2025, partially offsetting a 15% decline in legacy products facing generic competition. The company's stock gained 11.4% in the past month on strong fourth-quarter results.
The CAR T-Cell Therapy Market is estimated to reach USD 13.78 billion by 2031 from USD 7.24 billion in 2026, at a CAGR of 13.7%. The Cell & Gene Therapy Drug Delivery Devices Market is forecast to climb to USD 26.79 billion by 2032 from USD 3.39 billion in 2025.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07194980 |
Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
RECRUITING | PHASE2 |
| NCT07188558 |
A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy |
RECRUITING | PHASE3 |
| NCT07098364 |
ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed/Refractory Large B-Cell Lymphoma |
RECRUITING | PHASE1/PHASE2 |
| NCT06794268 |
A Study to Patients With Relapsed/Refractory Follicular Lymphoma Treated With Liso-cel (Lisocabtagene Maraleucel) in the Post Marketing Setting |
RECRUITING | |
| NCT06788652 |
A Study of Patients With Relapsed/Refractory Mantle Cell Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting |
RECRUITING | |
| NCT06788639 |
A Study of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting |
RECRUITING | |
| NCT06357754 |
Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Second Primary Malignancy |
RECRUITING | |
| NCT05873712 |
Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome |
RECRUITING | PHASE2 |
| NCT05672173 |
Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation |
RECRUITING | PHASE2 |
| NCT05633615 |
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma |
RECRUITING | PHASE2 |
