FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy

Basel, 15 July 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has granted Priority Review to the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (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/Gazyvaro over an immunosuppressive therapy, tacrolimus, in adults with pMN. 1 The FDA has already granted Breakthrough Therapy Designation (BTD) to Gazyva/Gazyvaro 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/Gazyvaro, following idiopathic nephrotic syndrome in May 2026.