SOUTH SAN FRANCISCO, Calif., July 14, 2026
Genentech, a member of the Roche Group, has received U.S. Food and Drug Administration (FDA) Priority Review for its supplemental Biologics License Application (sBLA) seeking approval of Gazyva® (obinutuzumab) for the treatment of primary membranous nephropathy (pMN), a rare chronic autoimmune kidney disease with no FDA-approved therapies currently available. The regulatory milestone is supported by the positive Phase III MAJESTY clinical trial, in which Gazyva demonstrated a statistically significant improvement in complete remission rates compared with the immunosuppressive therapy tacrolimus. The FDA has assigned a target action date in November 2026, following the therapy’s earlier Breakthrough Therapy Designation, highlighting the urgent need for innovative treatment options in patients with pMN. If approved, Gazyva would become the first FDA-approved therapy specifically indicated for primary membranous nephropathy, representing a major advancement in autoimmune kidney disease treatment and precision immunology.
Phase III MAJESTY Trial Demonstrates Superior Clinical Outcomes
The Phase III MAJESTY study evaluated Gazyva against tacrolimus in adults diagnosed with primary membranous nephropathy, a disease in which the immune system attacks the kidney’s filtering units, resulting in progressive protein loss and declining kidney function. According to the study, 36.9% of patients treated with Gazyva achieved complete remission after 104 weeks, compared with only 5.7% of patients receiving tacrolimus, representing a statistically significant treatment benefit. The investigational therapy also demonstrated superiority across important secondary endpoints, including overall remission rates and earlier achievement of complete remission. Importantly, the safety profile remained consistent with previously established clinical experience, with no new safety signals identified during the study. The clinical findings were presented as a late-breaking presentation at the 63rd European Renal Association Congress and simultaneously published in the New England Journal of Medicine, reinforcing the scientific significance of the results.
Potential First Approved Therapy for Primary Membranous Nephropathy
Primary membranous nephropathy remains a serious autoimmune disease affecting the kidneys, with approximately 30% of untreated patients progressing to kidney failure within ten years, creating a substantial clinical burden for patients and healthcare systems. By specifically targeting CD20-positive B cells, Gazyva addresses one of the underlying immune mechanisms responsible for disease progression while offering the potential to preserve kidney function through sustained disease remission. Genentech’s Chief Medical Officer Dr. Levi Garraway emphasized that achieving complete remission is essential for maintaining long-term kidney health and preventing progression to end-stage renal disease.
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The latest regulatory milestone further expands Gazyva’s growing role in immune-mediated diseases, following recent approvals in lupus nephritis and ongoing regulatory submissions in idiopathic nephrotic syndrome. Beyond nephrology, the therapy is already approved in more than 100 countries for several hematologic cancers, providing an established clinical foundation supporting broader immunology applications. The FDA’s Priority Review underscores both the strength of the MAJESTY clinical data and the urgent unmet medical need for patients with pMN. If approved later this year, Gazyva could redefine the standard of care by becoming the first targeted biologic approved for primary membranous nephropathy, expanding treatment options while reinforcing Genentech’s commitment to advancing innovative therapies across autoimmune and kidney diseases through precision immunology and evidence-based clinical research.
Source: Genentech press release
