FDA Approves Obinutuzumab (Gazyva) for Lupus Nephritis

The US Food and Drug Administration has approved Genentech’s obinutuzumab (Gazyva) 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.1

As described in an October 20, 2025, release from the Company, following 4 initial doses in the first year, obinutuzumab can be administered twice yearly, offering an effective and potentially more convenient treatment option than traditional targeted therapies. The approval is based on positive results from the phase 2 NOBILITY and phase 3 REGENCY studies.1

“As a severe and potentially life-threatening disease, lupus nephritis greatly disrupts daily life with chronic pain, fatigue, and the constant fear of worsening kidney health,” Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America, said in a statement.1 “The FDA’s approval of [obinutuzumab] offers renewed hope for people with lupus nephritis and their loved ones, as it provides an important new treatment option that has the potential to prevent long-term complications, including kidney failure.”

Obinutuzumab was granted FDA Breakthrough Therapy Designation in 2019 based on data from the phase 2 NOBILITY study. The Type II engineered humanized monoclonal antibody is designed to attach to CD20, a protein found on certain types of B cells, and is also being investigated in people with systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and in children and adolescents with lupus nephritis.1

Launched in 2020 following the success of the phase 2 NOBILITY trial, the phase 3 REGENCY trial was conducted at centers in 15 countries and included 271 patients 18-75 years of age who met the American College of Rheumatology classification criteria for systemic lupus erythematosus and had active class III or IV lupus nephritis with or without concomitant class V disease according to the classification of the International Society of Nephrology and the Renal Pathology Society.2

In REGENCY, data showed that nearly half of the participants (46.4%) on obinutuzumab in combination with standard therapy achieved a complete renal response compared to 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, all signaling improved disease control. The safety profile of obinutuzumab was consistent with the well-characterized profile observed in its hematology-oncology indications.1,2

“People with lupus nephritis who achieve a complete renal response are more likely to experience preserved kidney function and delay, or even prevention, of progression to end-stage kidney disease,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development.1 “The approval of Gazyva by the FDA marks an important step towards a potential new standard of care for lupus nephritis, one that could allow clinicians to offer their patients more effective disease control.”

References

1. Genentech. FDA Approves Genentech’s Gazyva for the Treatment of Lupus Nephritis. October 20, 2025. Accessed October 20, 2025. https://www.businesswire.com/news/home/20251019548091/en/FDA-Approves-Genentechs-Gazyva-for-the-Treatment-of-Lupus-Nephritis

2. Brooks A. FDA Accepts Obinutuzumab (Gazyva/Gazyvaro) sBLA for Lupus Nephritis. HCPLive. March 5, 2025. Accessed October 20, 2025. https://www.hcplive.com/view/fda-accepts-obinutuzumab-gazyva-gazyvaro-sbla-lupus-nephritis