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.
Phase 3 MAJESTY trial results show obinutuzumab led to 37% complete remission at 2 years vs 6% with tacrolimus in primary membranous nephropathy, with comparable safety. Genentech announced the positive data in February 2026, positioning obinutuzumab as a potential first approved therapy for PMN.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07774234 |
Sonrotoclax, Glofitamab, Gemcitabine, and Oxaliplatin for Relapsed or Refractory Large B-Cell Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07724457 |
Testing the Addition of a New Anti-Cancer Drug, Glofitamab to Usual Chemotherapy for Burkitt and Double Hit Lymphoma |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07721363 |
Obinutuzumab for Systemic Lupus Erythematosus Pure Membranous Nephropathy: a Phase II Trial |
NOT_YET_RECRUITING | PHASE2 |
| NCT07719855 |
A Multicenter, Prospective, Open-Label, Randomized Controlled Clinical Study of Orelabrutinib Combined With Obinutuzumab and Lenalidomide Versus Obinutuzumab Plus Chemotherapy for Treatment-Naive Follicular Lymphoma |
NOT_YET_RECRUITING | PHASE3 |
| NCT07719556 |
Orelabrutinib Combined With Obinutuzumab and Short-Course Venetoclax in Patients With Treatment-Naïve Mantle Cell Lymphoma (MCL) |
RECRUITING | PHASE2 |
| NCT07711483 |
GLORY: Glofit-GemOx With Liso-Cel For Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07690891 |
Nemtabrutinib With Venetoclax and Obinutuzumab in Patients With Chronic Lymphocytic Leukemia |
NOT_YET_RECRUITING | PHASE2 |
| NCT07674810 |
A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia |
NOT_YET_RECRUITING | PHASE2 |
| NCT07634289 |
Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07624799 |
Fixed Duration Treatment With Combined Pirtobrutinib and Short Course Immuno-chemotherapy in Fit Patients With Previously Untreated Symptomatic Chronic Lymphocytic Leukemia (CLL). |
NOT_YET_RECRUITING | PHASE2 |
