A U.S. decision is expected by November 2026 after phase III data showed Gazyva outperformed tacrolimus in adults with the autoimmune kidney disease, which has no FDA- or EMA-approved treatments.
The FDA has granted Priority Review to Roche’s supplemental Biologics License Application for Gazyva (obinutuzumab) in primary membranous nephropathy, with a decision expected by November 2026. The filing is backed by phase III MAJESTY data showing 36.9% of adults receiving Gazyva achieved complete remission at two years versus 5.7% on tacrolimus, meeting the study’s primary endpoint and supporting superiority over the immunosuppressive comparator. Roche said the FDA had already granted Breakthrough Therapy Designation to Gazyva in pMN in April 2026. If approved, Gazyva would become the first FDA-approved therapy for pMN, a chronic autoimmune kidney disease that currently has no approved treatments in the U.S. or Europe and can progress to kidney failure in up to 30% of patients over 10 years if left untreated.