FDA

Gazyva now approved for lupus nephritis

October 24, 2025

On October 19, 2025, FDA approved Gazyva (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients.

Efficacy

Approval was based on data from the Phase 2 NOBILITY (NCT02550652) and Phase 3 REGENCY (NCT04221477) studies. In REGENCY, results showed that nearly half of the participants (46.4%) on Gazyva in combination with standard therapy achieved a complete renal response (CRR) vs. 33.1% on standard therapy alone. This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, corticosteroid use, and proteinuria, indicating improved disease control.

Safety

The most common adverse reactions reported in lupus nephritis patients were upper respiratory tract infection, COVID-19, UTI, bronchitis, pneumonia, infusion-related reactions, and neutropenia.

Sources:

Gazyva (obinutuzumab) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125486s037s038lbl.pdf Revised October 2025. Accessed October 23, 2025.

FDA approves Genentech’s Gazyva for the treatment of lupus nephritis. [News release]. 2025. https://www.gene.com/media/press-releases/15085/2025-10-19/fda-approves-genentechs-gazyva-for-the-t