BASEL, Switzerland, July 15, 2026
Roche announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of primary membranous nephropathy (pMN). The application is supported by positive Phase 3 MAJESTY trial results demonstrating significantly higher complete remission rates compared with tacrolimus. If approved, Gazyva/Gazyvaro would become the first FDA-approved therapy for primary membranous nephropathy, with an FDA decision expected by November 2026.
Phase 3 MAJESTY Trial Demonstrates Superior Efficacy
The Phase 3 MAJESTY study met its primary endpoint, with 36.9% of adults receiving Gazyva/Gazyvaro achieving complete remission at Week 104, compared with 5.7% of patients treated with tacrolimus. The study also met key secondary endpoints, including significantly higher overall remission and earlier complete remission rates. Complete remission is considered the primary therapeutic goal in pMN because it helps preserve kidney function and reduces the risk of progression to kidney failure. The safety profile of Gazyva/Gazyvaro remained consistent with previous studies, with no new safety signals identified.
Priority Review Builds on Expanding Immunology Portfolio
The FDA previously granted Breakthrough Therapy Designation to Gazyva/Gazyvaro for pMN in April 2026. The Priority Review marks the second recent expedited regulatory designation for the therapy following a Priority Review for idiopathic nephrotic syndrome earlier this year. Roche has also submitted MAJESTY data to other global regulatory authorities, including the European Medicines Agency (EMA), while continuing to expand development of Gazyva/Gazyvaro across multiple immune-mediated diseases.
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Roche Expands Leadership in Immune-Mediated Kidney Diseases
Primary membranous nephropathy is a chronic autoimmune kidney disease with no FDA- or EMA-approved therapies currently available, and up to 30% of untreated patients may progress to kidney failure within ten years. Roche noted that Gazyva/Gazyvaro has already received approvals in the United States and European Union for lupus nephritis, supported by the REGENCY and NOBILITY studies, and continues to be evaluated in additional immune-mediated kidney disorders. The company believes the growing body of clinical evidence reinforces Gazyva/Gazyvaro’s potential to become an important treatment option across autoimmune kidney diseases while further strengthening Roche’s expanding immunology pipeline.
Source: Roche, press release
