Also known as: Gazyva
Gazyvaro is a trade name for obinutuzumab, a humanized anti-CD20 monoclonal antibody used in oncology and lupus nephritis settings. The medicine was first approved by the FDA in November 2013, with later approvals in additional indications. It is administered as an intravenous infusion.
FDA approves Genentech's Tecentriq as first ctDNA-guided adjuvant therapy for muscle-invasive bladder cancer, and Venclexta plus acalabrutinib as first all-oral fixed-duration regimen for CLL.
Experts discuss balancing efficacy and safety in BTK inhibitor plus venetoclax combination therapy for CLL, including BTK lead-in strategies to reduce tumor lysis syndrome risk and the benefits of all-oral fixed-duration regimens.
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
The FDA approved acalabrutinib plus venetoclax for previously untreated CLL/SLL based on phase 3 AMPLIFY data. The fixed 14-month regimen improved progression-free survival versus chemotherapy.
Roche reported its Phase III MAJESTY study in primary membranous nephropathy met its primary endpoint with Gazyva/Gazyvaro, positioning the medicine as a potential first approved treatment for this rare kidney condition.
Pharmac has proposed expanding access to melanoma treatments and funding two new therapies for chronic lymphocytic leukaemia. Medical researchers also highlight that New Zealanders lack access to CAR T-cell therapy domestically.
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.
Phase 3 trials demonstrate atrasentan slows kidney function decline in IgA nephropathy patients, while obinutuzumab achieves superior remission rates in primary membranous nephropathy compared to standard treatment.
The FDA approved the combination of acalabrutinib and venetoclax as the first all-oral, fixed-duration regimen for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma, based on Phase 3 AMPLIFY trial results.
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 |
|---|---|---|---|
| NCT07599423 |
A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed/Refractory Large B-Cell Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07520006 |
Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07502872 |
TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07480850 |
Efficacy and Safety of Glofitamab Combined With GemOxin the Treatment of Refractory Diffuse Large B-Cell Lymphoma |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT07326371 |
Glofitamab Combined With CAR-T Therapy in R/R DLBCL |
NOT_YET_RECRUITING | PHASE2 |
| NCT07268521 |
A Multicenter Phase 2 Single-arm Proof-of-concept Trial Assessing the Efficacy and Safety of Obinutuzumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Refractory or Intolerant to Rituximab |
NOT_YET_RECRUITING | PHASE2 |
| NCT07261163 |
Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma |
RECRUITING | PHASE2 |
| NCT07240194 |
The Efficacy and Safety of Glofitamab in Combination With PD-1 Antibody and Lenalidomide in Patients With Relapsed/Refractory Large B-cell Lymphoma (LBCL) With TP53 Aberrations: A Prospective, Multicenter, Phase II Clinical Study |
RECRUITING | PHASE2 |
| NCT07233330 |
Obinutuzumab in Adult Rituximab-Dependent Nephrotic Syndrome |
NOT_YET_RECRUITING | PHASE2 |
| NCT07218510 |
Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, LonGEVity Trial |
RECRUITING | PHASE2 |
