Follicular lymphoma is an indolent B-cell non-Hodgkin lymphoma that often grows slowly and may be discovered incidentally or with painless lymphadenopathy. Although typically not rapidly progressive, it can transform to a more aggressive lymphoma in some patients. Management depends on stage, symptoms, and tumor burden.
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.
The phase III frontMIND trial showed that adding tafasitamab and lenalidomide to R-CHOP chemotherapy reduced the risk of progression by 25% in patients with high-risk B-cell lymphomas. The 3-year progression-free survival was 67.3% with the combination versus 60.7% with R-CHOP alone. A dual-targeted CD19/CD20 immunotherapy regimen has also been approved in Australia for relapsed follicular lymphoma.
The FDA granted orphan drug designation to AstraZeneca’s surovatamig for follicular lymphoma. The status supports development for rare diseases but is only an early regulatory step.
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.
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.
Metabolic pathway scores consistently distinguished patients who developed severe neurologic events after CAR T-cell therapy across six clinical trials, surpassing traditional inflammatory markers in predictive performance.
Obinutuzumab demonstrated superior efficacy in two separate phase 3 trials for systemic lupus erythematosus and primary membranous nephropathy, with statistically significant improvements in remission rates and disease response measures.
Bristol-Myers Squibb received orphan drug designation from the FDA on Feb. 13 for a treatment targeting follicular lymphoma, a type of cancer affecting the lymphatic system.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07609446 |
Pomalidomide Plus Anti-CD20 Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma |
NOT_YET_RECRUITING | |
| NCT07585747 |
A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide |
NOT_YET_RECRUITING | PHASE2 |
| NCT07555470 |
Mosunetuzumab and Zeprumetostat in Treating Patients With Follicular Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07299149 |
Zanubrutinib, Obinutuzumab Combined With Lenalidomide (ZGR) for the Treatment of Untreated Follicular Lymphoma |
RECRUITING | PHASE2 |
| NCT07282548 |
Study of Tazemetostat in Adults With Follicular Lymphoma Previously Treated With at Least Two Therapies |
WITHDRAWN | |
| NCT07226843 |
A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers |
RECRUITING | PHASE1 |
| NCT07225439 |
Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) |
NOT_YET_RECRUITING | PHASE1 |
| NCT07191249 |
A Phase 2, Multicenter, Open-Label Trial to Evaluate Efficacy and Safety of Subcutaneous (SC) Mosunetuzumab in Previously Untreated Low Tumor Burden Follicular Lymphoma (LTB-FL). |
NOT_YET_RECRUITING | PHASE2 |
| NCT07187960 |
Evaluation of the Efficacy and Safety of TQB2825 Injection Compared to Immunotherapy in the Treatment of Recurrent/Refractory Follicular Lymphoma |
NOT_YET_RECRUITING | PHASE3 |
| NCT07168486 |
CD19.20.22 CAR T-cells for Patients With Relapsed/Refractory B-Cell Lymphomas |
ENROLLING_BY_INVITATION | PHASE1 |
