FDA grants Priority Review to Roche’s Gazyva (obinutuzumab) for primary membranous nephropathy after positive Phase III MAJESTY trial results.
Written By: Kalyani Boharapi,
M. Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Roche has announced that the U.S. Food and Drug Administration has granted Priority Review to the supplemental Biologics License Application for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of adults with primary membranous nephropathy (pMN). The application is supported by positive results from the Phase III MAJESTY study, which demonstrated the superiority of Gazyva/Gazyvaro over the immunosuppressive therapy tacrolimus. The FDA is expected to make its regulatory decision by November 2026.
If approved, Gazyva/Gazyvaro would become the first FDA-approved therapy specifically indicated for primary membranous nephropathy, a chronic autoimmune kidney disease for which there are currently no FDA- or EMA-approved treatments.
This marks the second recent Priority Review granted to Gazyva/Gazyvaro, following a Priority Review designation for idiopathic nephrotic syndrome in May 2026. The therapy also received Breakthrough Therapy Designation (BTD) for pMN in April 2026.
MAJESTY Trial Demonstrated Superior Remission Rates
The FDA’s Priority Review is based on findings from the Phase III MAJESTY study (NCT04629248), a randomized, open-label, multicenter trial involving 142 adults with primary membranous nephropathy. Participants were randomized 1:1 to receive either Gazyva/Gazyvaro or tacrolimus.
The study met its primary endpoint, with 36.9% of patients treated with Gazyva/Gazyvaro achieving complete remission at 104 weeks, compared with 5.7% of those receiving tacrolimus (adjusted difference 31.1%; 95% CI: 18.2–44.0; p<0.001).
Complete remission is considered the ultimate treatment goal in pMN because it helps preserve kidney function and may prevent progression to kidney failure. Gazyva/Gazyvaro also demonstrated superiority over tacrolimus in key secondary endpoints, including overall remission (complete or partial remission) at week 104 and complete remission at week 76. Its safety profile was consistent with the established experience of the drug, and no new safety signals were identified.
Addressing a Significant Unmet Need
Primary membranous nephropathy is a chronic autoimmune disease in which the immune system attacks the glomeruli, the kidney’s filtering units, causing protein leakage into the urine and progressive kidney damage. If left untreated, up to 30% of patients may progress to kidney failure over ten years, placing a substantial burden on patients, families, and healthcare systems.
According to Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, the Priority Review represents an important step toward providing patients with a therapy that targets tissue-resident B cells, addressing an underlying cause of pMN while potentially helping more patients achieve complete remission.
Regulatory and Development Progress
The MAJESTY results were presented as a late-breaking oral presentation at the 63rd European Renal Association (ERA) Congress in June 2026 and simultaneously published in the New England Journal of Medicine. Roche is also submitting the MAJESTY data to additional global regulatory authorities, including the European Medicines Agency (EMA).
MAJESTY represents the fourth positive Phase III study of Gazyva/Gazyvaro in immune-mediated diseases, following the REGENCY study in lupus nephritis, ALLEGORY in systemic lupus erythematosus, and INShore in idiopathic nephrotic syndrome.
Gazyva/Gazyvaro is already approved in the United States and European Union for adults with active lupus nephritis receiving standard therapy and is approved in more than 100 countries for several hematological malignancies. Roche is also evaluating obinutuzumab in the Phase II POSTERITY study in children and adolescents with lupus nephritis.
Gazyva/Gazyvaro is a humanized Type II anti-CD20 monoclonal antibody engineered to promote direct B-cell death while enhancing antibody-dependent cellular cytotoxicity, resulting in deep and sustained B-cell depletion across immune-mediated diseases.
References
FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy
About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.