FDA has granted priority review to obinutuzumab (Gazyva) for primary membranous nephropathy after phase 3 MAJESTY trial results showed superior remission versus tacrolimus.
FDA has granted priority review to Genentech's supplemental biologics application for obinutuzumab (Gazyva) for primary membranous nephropathy (pMN), the company announced on July 14, 2026. The decision is based on positive phase 3 MAJESTY results, and an FDA decision is expected by November 2026. If approved, obinutuzumab would be the first FDA-approved therapy for pMN, a chronic autoimmune kidney disease with no approved treatments.1
"This priority review represents an important step for patients living with primary membranous nephropathy, a chronic disease with no FDA-approved treatments," said
The phase 3 MAJESTY trial (NCT04629248) randomized 142 adults with pMN 1:1 to obinutuzumab or tacrolimus.2,4 The study met its primary endpoint: 36.9% of patients achieved complete remission at 2 years (week 104) with obinutuzumab versus 5.7% with tacrolimus (adjusted difference, 31.1 percentage points; 95% confidence interval, 18.2-44.0; p<0.001).1,2
Obinutuzumab also outperformed tacrolimus on key secondary endpoints, including overall remission at week 104 and complete remission at week 76. Safety was consistent with obinutuzumab's known profile, with no new signals identified. Results were presented as a late-breaking oral presentation at the 63rd European Renal Association Congress in June 2026 and published in the New England Journal of Medicine.1,2
pMN is a chronic autoimmune disease in which the immune system attacks the kidney's filtering units (glomeruli), causing protein to leak into urine and kidney function to decline over time. Left untreated, up to 30% of patients progress to kidney failure within 10 years, carrying burden for patients and health systems.1
pMN has an estimated US incidence of 1.2 per 100,000 people annually; no therapy is FDA- or EMA-approved for the condition.1
Obinutuzumab is a humanized monoclonal antibody engineered with a type 2 anti-CD20 binding region that promotes direct B-cell death, plus a glycoengineered Fc region for increased antibody-dependent cellular cytotoxicity. CD20 is expressed on B cells implicated in pMN's underlying autoimmune process.
Obinutuzumab is approved in the US and EU for active lupus nephritis, based on the phase 3 REGENCY and phase 2 NOBILITY trials, and in 100 countries for hematologic cancers. MAJESTY is the fourth positive phase 3 study of obinutuzumab in immune-mediated disease, following REGENCY, ALLEGORY in systemic lupus erythematosus, and INShore in idiopathic nephrotic syndrome, which also received FDA priority review.1
A 31-percentage-point difference in complete remission suggests a meaningful effect size, given no prior therapy has shown superiority to standard immunosuppression in a randomized, head-to-head pMN trial. Because complete remission tracks closely with long-term kidney function, the finding suggests a possible shift in first-line treatment strategy if approved.1
Genentech frames results as evidence that targeting tissue-resident B cells addresses an underlying mechanism, rather than broadly suppressing immunity as tacrolimus does.1 Confirmation of durability beyond 2 years, and of relapse after discontinuation, may help contextualize the drug's role.
MAJESTY was open-label, which can introduce bias in subjective outcomes, and enrolled a modest 142 patients, a common constraint in rare kidney disease trials.2,4 Relapse and safety data beyond 2 years have not yet been reported.
FDA's priority review sets an expected decision date near November 2026. MAJESTY data have also been submitted to the European Medicines Agency and other regulators, with outcomes pending.1
