Healthcare
FDA Grants Priority Review to Genentech’s Gazyva for Adults With Primary Membranous Nephropathy
SOUTH SAN FRANCISCO, Calif., July 15, 2026--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, t
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SOUTH SAN FRANCISCO, Calif., July 15, 2026 --( BUSINESS WIRE )--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. "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, M.D., Ph.D., chief medical officer and head of Global Product Development. "By targeting tissue-resident B cells, Gazyva 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 met its primary endpoint with 36.9% of adults achieving complete remission (CR) at two years (104 weeks) with Gazyva versus 5.7% with tacrolimus (adjusted difference 31.1%; 95% confidence interval [CI] 18.2 to 44.0; p<0.001). Complete remission is the ultimate goal in pMN and can help prevent progression to kidney failure. Key secondary endpoints showed that Gazyva was superior to tacrolimus in achieving overall remission (complete or partial remission) at week 104 and complete remission at week 76. Safety was in line with the well-characterized profile of Gazyva and no new safety signals were identified.