Posted by Michael Wonder on 17 Jul 2026
FDA grants priority review to Genentech’s Gazyva for adults with primary membranous nephropathy
14 July 2026 - Genentech announced today that the US FDA has granted priority review to the company’s supplemental biologics license application for Gazyva (obinutuzumab) for the treatment of primary membranous nephropathy (pMN).
The priority review is based on the positive Phase 3 MAJESTY results, which show superiority of Gazyva over an immunosuppressive therapy, tacrolimus, in adults with pMN. The FDA has already granted breakthrough therapy designation 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 US FDA has granted priority review to Gazyva following idiopathic nephrotic syndrome in May 2026.
