The FDA has approved Roche’s Gazyva for lupus nephritis, marking the first anti-CD20 biologic proven effective for this serious autoimmune kidney complication.
October 20, 2025
Source:
Roche Pharmaceuticals
New FDA Clearance Expands Gazyva Beyond Oncology
Roche’s Gazyva (obinutuzumab), previously approved for certain blood cancers, is now FDA-cleared for adult patients with active lupus nephritis (LN), based on landmark trial results. This is the first anti-CD20 monoclonal antibody to show superior renal outcomes in this condition. (FDA press release)
Clinical Study Highlights
NOBILITY and REGENCY pivotal studies drove approval.
In phase III, 46.4% of patients on Gazyva plus standard therapy achieved complete renal response versus 33.1% with standard therapy alone.
Additional improvements noted in autoantibody levels, corticosteroid use, and proteinuria.
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Impact for Lupus Nephritis Treatment
Addressing a Critical Unmet Need
Lupus nephritis is a severe kidney inflammation tied to lupus; it affects over 1.7 million people worldwide and commonly leads to kidney failure (Lupus Foundation of America).
Achieving complete renal response can delay or prevent kidney failure, directly affecting patient survival and quality of life.
Previously, no FDA-approved anti-CD20 biologic existed for this indication.
Convenience and Administration
The new regimen includes a shorter, 90-minute infusion after the initial dose, and maintenance therapy is required only twice a year. This is expected to improve adherence compared to more frequent dosing schedules.
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Source:
U.S. Food and Drug Administration
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