Roche (SIX: RO; OTCQX: RHHBY) announced that the US FDA has granted Priority Review to its supplemental Biologics License Application (sBLA) for obinutuzumab (Gazyva/Gazyvaro), a glycoengineered type II anti-CD20 monoclonal antibody, for the treatment of primary membranous nephropathy (pMN) in adults — a condition for which neither the FDA nor the European Medicines Agency (EMA) has approved any therapy to date. The designation positions obinutuzumab for a regulatory decision by November 2026 and, if approved, would make it the first labelled treatment for pMN.
The MAJESTY trial results that underpin the sBLA were published in the New England Journal of Medicine and presented as a late-breaking oral at the 63rd European Renal Association Congress in June 2026. The Phase III MAJESTY study enrolled 142 adults with pMN, randomized 1:1 to obinutuzumab or tacrolimus. The primary endpoint — complete remission (CR) at 104 weeks — was met with 36.9% of patients in the obinutuzumab arm achieving CR versus 5.7% in the tacrolimus arm (adjusted difference 31.1%; 95% CI 18.2–44.0; p<0.001). Key secondary endpoints, including overall remission (complete or partial) at week 104 and CR at week 76, also favored obinutuzumab, with statistically significant differences on both measures. Safety was consistent with obinutuzumab's established profile across its approved indications, and no new signals were identified.
Obinutuzumab depletes B cells through two structural features that distinguish it from earlier anti-CD20 agents: a type II binding domain that induces direct, nonapoptotic B-cell death, and a glycoengineered Fc region that enhances antibody-dependent cellular cytotoxicity (ADCC). In pMN, autoreactive B cells generate pathogenic autoantibodies — most commonly directed against the phospholipase A2 receptor on kidney podocytes — that drive immune complex deposition and progressive glomerular damage. Depleting those B cells upstream is the mechanistic basis for the MAJESTY trial design.
The Priority Review designation follows Breakthrough Therapy Designation (BTD) granted to obinutuzumab for pMN in April 2026, and is the second Priority Review Roche has received for the molecule in recent months, after an equivalent designation for idiopathic nephrotic syndrome in May 2026. The accumulation of expedited designations across multiple immune-mediated kidney diseases reflects the breadth of the clinical program Roche has built around obinutuzumab beyond its oncology origins. As previously reported, Roche also filed an sBLA for obinutuzumab in systemic lupus erythematosus (SLE) following positive Phase III ALLEGORY data, with a regulatory decision expected by December 2026.