FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy

Roche has recently confirmed that the US FDA  has granted Priority Review to a supplemental Biologics License Application for Gazyva/Gazyvaro for the treatment of primary membranous nephropathy. The designation rests on positive Phase III MAJESTY results demonstrating the superiority of Gazyva/Gazyvaro over tacrolimus, an immunosuppressive therapy, in adults with the condition. The FDA had previously granted Breakthrough Therapy Designation to Gazyva/Gazyvaro in primary membranous nephropathy and is expected to reach a decision on approval by November 2026. This marks the second indication in recent months for which the FDA has granted Priority Review to Gazyva/Gazyvaro, following idiopathic nephrotic syndrome in May 2026.

“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 Phase III MAJESTY study cleared its primary endpoint, with 36.9% of adults reaching complete remission at two years with Gazyva/Gazyvaro against just 5.7% with tacrolimus. Complete remission is considered the gold standard outcome in primary membranous nephropathy and plays a critical role in preventing the disease from progressing to kidney failure. Key secondary endpoints further confirmed the superiority of Gazyva/Gazyvaro over tacrolimus, with greater rates of overall remission and complete remission at earlier timepoints also achieved. The safety profile remained consistent with the well-established characteristics of Gazyva/Gazyvaro, and no new concerns emerged.

The findings were highlighted at the 63rd European Renal Association Congress in June 2026 as a late-breaking oral presentation and published simultaneously in the New England Journal of Medicine. Data from MAJESTY are also being submitted to other regulatory authorities worldwide, including the European Medicines Agency.

Primary membranous nephropathy is a chronic autoimmune disease that inflicts potentially irreversible damage on the kidneys and can ultimately lead to kidney failure, placing a significant burden on patients, their families, and healthcare systems alike. Reaching complete remission is a critical objective in preserving kidney function and delaying or preventing the onset of serious and potentially life-threatening complications.

MAJESTY stands as the fourth positive Phase III study of Gazyva/Gazyvaro in immune-mediated diseases, joining earlier successes in lupus nephritis, systemic lupus erythematosus, and idiopathic nephrotic syndrome, where the therapy also received Priority Review and Breakthrough Therapy Designation from the FDA. Gazyva/Gazyvaro is approved in both the US and EU for adults with active lupus nephritis receiving standard therapy, and is currently being investigated in the Phase II POSTERITY study for children and adolescents with lupus nephritis. The expanding body of evidence across these conditions underscores the breadth of Gazyva/Gazyvaro’s potential across the spectrum of immune-mediated disease.

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Related Topics and Keywords

FDA, Gazyvaro, Nephropathy, Primary Membranous Nephropathy, Roche's Gazyva