Lupus nephritis is a serious manifestation of systemic lupus erythematosus, an autoimmune disorder affecting the kidneys. The disease leads to irreversible loss of nephrons, the kidney’s filtering units. This damage is accelerated by repeated disease flares, resulting in progressive kidney failure. Regardless of the treatment options, a significant number of patients progress to end-stage kidney disease, for which dialysis or kidney transplantation are the only treatment options. As no cure exists, new therapies such as Gazyva represent an important step forward in improving survival and quality of life.
Gazyva is a Type II humanized monoclonal antibody that is engineered to bind to a protein called CD20 of some B cells. Lupus nephritis involves disease-causing B cells, which cause chronic inflammation that destroys kidney tissue and impairs kidney function. Gazyva can reduce the extent of further damage by destroying these B cells and possibly stop or delay the onset of kidney failure. Gazyva is commercially available in the United States in partnership between Biogen and Genentech and has been approved in over 100 countries for various blood cancers.
Over 1.7 million people around the world are affected by lupus nephritis, mostly women of color and childbearing age. Without timely treatment, up to one-third of the affected people can develop end-stage kidney disease that would need dialysis or transplantation. In 2019, Gazyva was granted Breakthrough Therapy Designation by the FDA after a positive result of the NOBILITY study. The Committee of Medicinal Products to Human Use at the European Medicines Agency has also published a positive opinion suggesting the approval of Gazyva in the treatment of adults with active lupus nephritis, and a final ruling by the European Commission is likely to be made shortly.
Genentech has introduced Gazyva (obinutuzumab) for the treatment of adult patients with active lupus nephritis who are receiving standard therapy. This approval is a milestone since Gazyva is the only anti-CD20 monoclonal antibody to exhibit complete renal response advantages on a randomized Phase III trial. Treatment has also been made easier as the FDA has allowed a reduced infusion time of 90 minutes to eligible patients once they receive their initial dose. Gazyva may be given twice a year after the first four doses during the first year, which offers an effective and possibly more convenient way of treatment than the conventional targeted therapies.
Genentech Chief Medical Officer and Head of Global Product Development, Dr. Levi Garraway, discussed the fact that lupus nephritis patients who have a complete renal response would be more likely to maintain kidney function and delay the development of end-stage kidney disease. According to him, this approval marks significant progress toward establishing a new standard of care in lupus nephritis, enabling doctors to provide better disease control for their patients.
According to Louise Vetter, President and Chief Executive Officer of the Lupus Foundation of America, lupus nephritis is a serious and possibly fatal condition that affects everyday life with chronic pains, tiredness, and fear of kidney damage. According to her, the FDA’s approval of Gazyva has brought new hope to patients and their families by offering a treatment option with the potential to prevent chronic complications such as kidney failure.
Strong findings in Phase II NOBILITY and Phase III REGENCY studies formed the basis of the FDA’s decision. In the REGENCY trial, 46.4% of the patients who were treated with Gazyva in combination with the standard therapy showed complete renal response, compared with 33.1% of the patients treated with the standard therapy alone.
The REGENCY trial was a randomized, controlled (Phase III), placebo-controlled, multicenter trial that involved 271 patients with Class III or IV lupus nephritis, with or without Class V, who were treated with Gazyva and standard therapy or placebo and standard therapy. The researchers investigated the COVID-19 pandemic and used a population representative of individuals with lupus nephritis in the actual context.
Reference: Genentech. FDA Approves Genentech’s Gazyva for the Treatment of Lupus Nephritis. Published Oct 19, 2025. Accessed Oct 22, 2025. FDA Approves Genentech’s Gazyva for the Treatment of Lupus Nephritis
