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# Genentech’s Gazyva Approved for Lupus Nephritis
- URL: https://www.fdaweb.com/genentechs-gazyva-approved-for-lupus-nephritis/
- Published: 2025-10-21T12:00:00.000Z
- Updated: 2026-09-14T15:24:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160081

FDA has approved Genentech’s Gazyva (obinutuzumab) for treating adult patients with active lupus nephritis who are receiving standard therapy. The approval makes Gazyva the first anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in a Phase 3 trial of lupus nephritis patients, according to the company.

The approval was supported by data from the Phase 2 NOBILITY and Phase 3 REGENCY trials, which showed that adding Gazyva to standard therapy resulted in significantly higher rates of complete renal response (CRR) compared with standard therapy alone. In REGENCY, 46.4% of patients treated with Gazyva achieved CRR compared to 33.1% of those on standard therapy alone, Genentech says. The Gazyva arm also showed improvements in complement levels, anti-dsDNA antibodies, corticosteroid use, and proteinuria, signaling better disease control. Safety findings were consistent with the antibody’s established profile in its oncology indications, it says.

Gazyva is described by Genentech as a Type 2 engineered monoclonal antibody that targets CD20, a protein expressed on B cells. By depleting disease-causing B cells, the therapy helps control inflammation that leads to kidney damage in lupus nephritis, it says.