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.
Swissmedic has authorized three orphan drugs for rare diseases: Breyanzi for mantle cell lymphoma, Alhemo for haemophilia A and B, and Ekterly for hereditary angioedema. The decisions include a new indication extension for Breyanzi, an expanded indication for Alhemo, and the initial authorization of Ekterly as part of a joint international regulatory initiative.
Real-world studies show early complete response after CAR T-cell therapy predicts sustained remission in large B-cell lymphoma, while historical chemotherapy yields poor outcomes in high-risk patients. Data from registries highlight a significant event-free survival advantage for second-line axicabtagene ciloleucel versus standard-of-care salvage therapy.
Long-term results from the phase III TRIANGLE trial show ibrutinib-based regimens improve survival in younger mantle cell lymphoma patients, while the ECHO trial establishes a new standard for older patients. Advances in CAR T-cell and bispecific antibody therapies are reshaping treatment for this rare blood cancer. The findings were presented at the annual MCL Consortium meeting.
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.
| 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 |
