Mantle cell lymphoma is an aggressive and uncommon B-cell non-Hodgkin lymphoma arising from the mantle zone of lymph nodes. It often presents at advanced stage and requires systemic therapy.
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.
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.
FDA launched two proof-of-concept real-time clinical trials on April 28, 2026, and issued an RFI for an AI-focused pilot program to optimize early-phase trials. The agency aims to reduce gaps between trial phases and modernize drug development.
Ascentage Pharma said six clinical abstracts were selected for ASCO 2026 and four preclinical studies will be presented at AACR 2026. The presentations feature olverembatinib and other pipeline candidates.
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.
New antibody-based approaches demonstrate clinical benefits across multiple cancer types, including improved survival in triple-negative breast cancer, enhanced tumor detection via PET imaging, and activity in relapsed mantle cell lymphoma.
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.
Recent studies demonstrate zanubrutinib delivers higher response rates, longer treatment persistence, and lower healthcare costs compared to acalabrutinib and ibrutinib across multiple B-cell malignancies, with particularly strong benefits in high-risk populations.
FDA approves AstraZeneca's Calquence plus venetoclax as first all-oral, 14-month fixed-duration regimen for first-line chronic lymphocytic leukemia, with 77% of patients progression-free at three years in Phase III trial.
The FDA has approved the combination of acalabrutinib and venetoclax as the first all-oral, fixed-duration BTK inhibitor-based regimen for previously untreated adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07592481 |
Connected Blood Pressure Monitoring in Patients With Hematologic Malignancies Initiating Covalent BTK Inhibitors |
NOT_YET_RECRUITING | NA |
| NCT07453095 |
Study With Glofitamab in Patients With MCL and Inadequate Response or Relapse Following CAR T-cell Therapy |
NOT_YET_RECRUITING | PHASE2 |
| NCT07377578 |
A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma |
RECRUITING | PHASE3 |
| NCT07341191 |
Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy |
RECRUITING | PHASE2 |
| NCT07285044 |
The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas |
RECRUITING | PHASE2 |
| NCT07261163 |
Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma |
RECRUITING | PHASE2 |
| 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 |
| NCT07207785 |
PirtobrUtinib as Frontline Therapy for Elderly Unfit/Frail Patient With MAntle Cell Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07206264 |
Chemotherapy Combined With Targeted Therapy as First-line Treatment for Mantle Cell Lymphoma Based on MRD and PET-CT Assessment |
NOT_YET_RECRUITING | PHASE2 |
| NCT07168486 |
CD19.20.22 CAR T-cells for Patients With Relapsed/Refractory B-Cell Lymphomas |
ENROLLING_BY_INVITATION | PHASE1 |
