FDA Approves Obinutuzumab for Active Lupus Nephritis in Adults

The U.S. Food and Drug Administration (FDA) has approved Genentech’s obinutuzumab for the treatment of adult patients with active lupus nephritis (LN) receiving standard therapy. The approval also includes a shorter 90-minute infusion time after the first dose, providing a more efficient treatment experience.

Study Findings

This decision is supported by data from the Phase II NOBILITY and Phase III REGENCY trials. In REGENCY, 46.4% of participants treated with obinutuzumab plus standard therapy of glucocorticoids and immunomodulators, achieved a complete renal response (CRR), compared with 33.1% of those receiving standard therapy alone. Patients on obinutuzumab demonstrated improvements in complement levels, anti-dsDNA antibodies, and reductions in corticosteroid use and proteinuria—key indicators of improved renal and systemic disease control.

Obinutuzumab previously received Breakthrough Therapy Designation from the FDA in 2019 following the NOBILITY trial results.

The safety profile of obinutuzumab— a Type II engineered humanized monoclonal antibody designed to attach to CD20—was consistent with its established use in hematologic malignancies. After 4 doses in the first year, eligible patients can continue with twice-yearly infusions, offering both sustained efficacy and convenience.

Clinical Implications

Lupus nephritis, a severe manifestation of systemic lupus erythematosus (SLE), affects approximately 1.7 million people worldwide. The disease disproportionately impacts women—particularly women of color—during their reproductive years. Without adequate treatment, up to one-third of patients may progress to end-stage kidney disease, necessitating dialysis or transplantation.

With the approval of obinutuzumab clinicians managing lupus nephritis have a new option, complementing existing immunosuppressive regimens. Its demonstrated ability to improve renal outcomes while reducing steroid dependence may represent a significant advancement in preserving kidney function and quality of life for patients.

The most common side effects of obinutuzumab in LN were upper respiratory tract infection, COVID-19, urinary tract infection, bronchitis, pneumonia, infusion infusion-related reactions, and neutropenia.

Reference:
FDA approves Genentech’s Gazyva for the treatment of adults with active lupus nephritis. Genentech; Press release. October 19, 2025. https://www.gene.com/media/press-releases/15085/2025-10-19/fda-approves-genentechs-obinutuzumab -for-the-t Accessed October 20, 2025.