FDA Grants Priority Review to Genentech’s Gazyva for Adults With Primary Membranous Nephropathy
Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus
If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome
pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) for the treatment of primary membranous nephropathy (pMN). The priority review is based on the positive Phase III MAJESTY results, which show superiority of Gazyva over an immunosuppressive therapy, tacrolimus, in adults with pMN. The FDA has already granted Breakthrough Therapy Designation (BTD) to Gazyva 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 U.S. FDA has granted priority review to Gazyva following idiopathic nephrotic syndrome in May 2026.
