FDA approves Gazyva for adults with primary membranous nephropathy at risk of progression
The FDA approved Gazyva (obinutuzumab) for adults with primary membranous nephropathy, with complete remission of proteinuria at week 104 in 36% versus 6% on tacrolimus in MAJESTY. The FDA said it is the first drug approved specifically for these adults.
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The U.S. Food and Drug Administration approved Gazyva (obinutuzumab) injection for adults with primary membranous nephropathy at risk of disease progression, to induce remission of proteinuria, the FDA said. In the MAJESTY study, 36% of patients on Gazyva reached complete remission at week 104, compared with 6% on tacrolimus. The FDA called it the first drug approved specifically for these adults.
| Arm | Complete remission at week 104 | Primary membranous nephropathy |
|---|---|---|
| Gazyva (obinutuzumab) | 36% | Approved by the FDA |
| Tacrolimus | 6% | Sometimes used off-label |
From the FDA page on the approval, current as of 11/13/2026, which cites the MAJESTY study (NCT04629248).
Why it matters
Gazyva was previously approved for treating certain cancers, active lupus nephritis, and childhood-onset idiopathic nephrotic syndrome, the FDA said. The FDA described tacrolimus, the comparator in MAJESTY, as another treatment sometimes used off-label for primary membranous nephropathy. The approval adds a labeled option for a rare kidney disease in which the FDA says patients can develop high cholesterol, high blood pressure, severe swelling, fatigue and kidney failure.
Approval and results
The FDA page was current as of 11/13/2026. The FDA said the efficacy and safety of Gazyva were evaluated in MAJESTY (NCT04629248), a Phase 3, randomized, controlled, open-label, multicenter study in 142 adults with primary membranous nephropathy.
- Main study period: 104 weeks, with patients randomly assigned to Gazyva or tacrolimus.
- Primary outcome: the proportion of patients who achieved complete remission of proteinuria.
- complete remission was defined as a urine protein-creatinine ratio (UPCR) of no more than 0.3 g/g with a stable estimated glomerular filtration rate (eGFR) at week 104, without receipt of rescue therapy, treatment failure, or early study discontinuation.
- Result: 36% in the Gazyva group and 6% in the tacrolimus group. The FDA said the proportion was significantly higher with Gazyva.
Safety information
According to the FDA, Gazyva's label carries a boxed warning for hepatitis B virus reactivation and progressive multifocal leukoencephalopathy (PML), a rare and serious brain infection caused by a virus in people with a weakened immune system. The most common side effects seen in the primary membranous nephropathy study were infusion-related reactions and upper respiratory tract infection. The FDA points readers to the full prescribing information for complete safety details.
Designations
The FDA said Gazyva received Breakthrough Therapy, Orphan Drug, and Priority Review designations for this approval.