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news.The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental biologics licence application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) to treat adults with primary membranous nephropathy (pMN).
pMN is a chronic autoimmune disease that can result in kidney damage and may progress to kidney failure. Credit: sasirin pamai / Shutterstock.com.
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The decision is based on results from the Phase III MAJESTY study, which indicated that Gazyva/Gazyvaro achieved a higher rate of complete remission at two years compared to tacrolimus, an immunosuppressive therapy.
In the trial, 36.9% of participants receiving Gazyva/Gazyvaro achieved complete remission at week 104 versus 5.7% for those treated with tacrolimus.
The adjusted difference was 31.1%. Secondary endpoints showed benefits for Gazyva/Gazyvaro in overall remission and remission at week 76. Safety findings aligned with the known profile for Gazyva/Gazyvaro and no new safety issues were observed.
pMN is a chronic autoimmune disease that can result in lasting kidney damage and may progress to kidney failure.
Roche chief medical officer and global product development head Levi Garraway said: “This priority review represents an important step for patients living with primary membranous nephropathy, a chronic disease with no FDA-approved treatments.
“By targeting tissue-resident B cells, Gazyva/Gazyvaro addresses an underlying cause of pMN and has the potential to help more patients achieve complete remission — a necessary step to maintaining kidney function.”
The FDA had previously granted breakthrough therapy designation for Gazyva/Gazyvaro in primary membranous nephropathy in April 2026. A decision on approval is expected by November 2026.
Gazyva/Gazyvaro also received FDA Priority Review for idiopathic nephrotic syndrome in May 2026. Data from MAJESTY were presented at the 63rd European Renal Association Congress in June 2026 and published in the New England Journal of Medicine.
Primary membranous nephropathy has no approved therapies from the FDA or European Medicines Agency.
Estimates suggest up to 30% of untreated patients progress to kidney failure after ten years. Gazyva/Gazyvaro is already approved for lupus nephritis in the US and EU, and applications are ongoing in other indications.
Last month, Roche received the FDA priority review for its sBLA for adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy for colon cancer.
