Genentech’s Gazyva (obinutuzumab) granted FDA priority review for primary membranous nephropathy

Regulatory update

The FDA has granted priority review to Genentech’s supplemental Biologics License Application for Gazyva (obinutuzumab) in primary membranous nephropathy (pMN). The filing is supported by Phase III MAJESTY data; the FDA previously granted Breakthrough Therapy Designation and is expected to issue a decision by November 2026. This follows a May 2026 priority review for idiopathic nephrotic syndrome.

Phase III MAJESTY results

MAJESTY randomized 142 adults 1:1 to Gazyva or tacrolimus with the primary endpoint of complete remission (CR) at week 104. CR was achieved in 36.9% of patients on Gazyva versus 5.7% on tacrolimus (adjusted difference 31.1%; 95% CI 18.2 to 44.0; p<0.001). Gazyva also showed superiority for overall remission at week 104 and CR at week 76. Safety was consistent with the established profile of Gazyva and no new safety signals were identified.

Clinical context

Primary membranous nephropathy is a chronic autoimmune disease that can cause irreversible kidney damage and lead to kidney failure and other serious complications. Achieving complete remission is important to maintain kidney function. The condition’s incidence in the U.S. is estimated at 1.2 per 100,000 per year, and untreated patients may progress to kidney failure in up to 30% of cases over 10 years.

Next steps and dissemination

MAJESTY data were presented as a late-breaking oral at the 63rd ERA Congress and published in the New England Journal of Medicine. Genentech is submitting the data to other global health authorities, including the European Medicines Agency.