FDA Grants Priority Review to Roche’s Gazyva/Gazyvaro for Primary Membranous Nephropathy
Wednesday, July 15, 2026
Roche has announced that the US Food and Drug Administration (FDA) has granted Priority Review to its supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) as a treatment for adults with primary membranous nephropathy (pMN).
The application is supported by positive results from the Phase 3 MAJESTY trial, which showed that Gazyva/Gazyvaro was more effective than the immunosuppressive therapy tacrolimus in treating adults with pMN. The FDA is expected to make its approval decision by November 2026.
In the MAJESTY study, 36.9% of patients treated with Gazyva/Gazyvaro achieved complete remission after 104 weeks, compared with 5.7% of patients receiving tacrolimus. The treatment also met key secondary endpoints, demonstrating higher overall and complete remission rates. Its safety profile was consistent with previous studies, with no new safety concerns identified.
The FDA had previously granted Breakthrough Therapy Designation to Gazyva/Gazyvaro for pMN. This marks the second Priority Review awarded to the therapy in recent months, following its review for idiopathic nephrotic syndrome in May 2026.
The Phase 3 MAJESTY data were presented at the 63rd European Renal Association (ERA) Congress in June 2026 and published in the New England Journal of Medicine. Roche is also submitting the data to other regulatory authorities, including the European Medicines Agency.
Primary membranous nephropathy is a chronic autoimmune kidney disease that can lead to irreversible kidney damage and kidney failure. Roche said achieving complete remission is important for preserving kidney function and reducing the risk of disease progression.
The positive MAJESTY results represent the fourth successful Phase 3 study of Gazyva/Gazyvaro in immune-mediated diseases, supporting the company's broader strategy to expand the therapy's use beyond its existing approved indications in lupus nephritis and haematological cancers.
Source: globenewswire.com
