FDA Grants Priority Review To Roche's Gazyva For Primary Membranous Nephropathy

Roche has received Priority Review from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of primary membranous nephropathy (pMN). The regulatory decision follows positive results from the Phase III MAJESTY trial, which demonstrated superior efficacy compared with the immunosuppressive therapy tacrolimus in adults with the disease. The FDA is expected to make its approval decision by November 2026.

The MAJESTY study achieved its primary endpoint, with 36.9% of patients treated with Gazyva/Gazyvaro achieving complete remission after two years, compared with 5.7% of patients receiving tacrolimus. The therapy also showed advantages in key secondary endpoints, including higher rates of both overall remission and earlier complete remission. Importantly, the safety profile remained consistent with previous studies and no new safety concerns were identified.

“This priority review represents an important step for patients living with primary membranous nephropathy, a chronic disease with no FDA-approved treatments," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “By targeting tissue-resident B cells, Gazyva/Gazyvaro addresses an underlying cause of pMN and has the potential to help more patients achieve complete remission - a necessary step to maintaining kidney function.”

The FDA had previously granted Breakthrough Therapy Designation to Gazyva/Gazyvaro for pMN in April 2026, and the latest Priority Review marks the second recent kidney disease indication to receive expedited regulatory attention after idiopathic nephrotic syndrome earlier this year. Findings from the MAJESTY trial were presented as a late-breaking presentation at the 2026 European Renal Association Congress and were simultaneously published in the New England Journal of Medicine.

Primary membranous nephropathy is a chronic autoimmune kidney disease that can lead to irreversible kidney damage and eventual kidney failure if left uncontrolled. Roche is also pursuing regulatory submissions for the indication in other regions, including Europe. The positive MAJESTY results add to a growing body of evidence supporting Gazyva/Gazyvaro across immune-mediated diseases, including lupus nephritis, systemic lupus erythematosus, and idiopathic nephrotic syndrome, while the company continues to expand its broader immunology pipeline.