Roche announced that the US Food and Drug Administration (FDA) has granted Priority Review (PR) to the company’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of primary membranous nephropathy (pMN). The PR is based on the positive phase 3 MAJESTY results, which show superiority of Gazyva/Gazyvaro over an immunosuppressive therapy, tacrolimus, in adults with pMN.

The FDA has already granted Breakthrough Therapy Designation (BTD) to Gazyva/Gazyvaro in pMN and is expected to make a decision on approval by November 2026. This is the second indication in recent months for which the FDA has granted PR to Gazyva/Gazyvaro, following idiopathic nephrotic syndrome in May 2026.

Levi Garraway, MD, PhD, Chief Medical Officer (CMO) and Head of Global Product Development, Roche, said, “This Priority Review represents an important step for patients living with pMN, a chronic disease with no FDA-approved treatments. 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 (CR)- a necessary step to maintaining kidney function.”

The phase 3 MAJESTY study met its primary endpoint, with 36.9 percent of adults achieving CR at 2 years (104 weeks) with Gazyva/Gazyvaro versus 5.7 percent with tacrolimus (adjusted difference 31.1 percent; 95 percent confidence interval [CI] 18.2 to 44.0; p<0.001). CR is the ultimate goal in pMN and can help prevent progression to kidney failure. Key secondary endpoints showed that Gazyva/Gazyvaro was superior to tacrolimus in achieving overall remission (complete or partial remission) at week 104 and CR at week 76. Safety was in line with the well-characterised profile of Gazyva/Gazyvaro and no new safety signals were identified.

The data were featured at the 63rd European Renal Association (ERA) Congress in June 2026 as a late-breaking oral presentation and published in the New England Journal of Medicine (NEJM).

In April 2026, the FDA granted Breakthrough Therapy Designation (BTD) for Gazyva/Gazyvaro in pMN.

Data from MAJESTY are also being submitted to other global health authorities, including the European Medicines Agency (EMA).

pMN is a chronic autoimmune condition that causes potentially irreversible kidney damage and can lead to kidney failure, which has a significant impact on patients and their families, while carrying substantial burden to health systems. Achieving CR is important to help maintain kidney function and delay or prevent the onset of serious and potentially fatal complications.