Written By: Shreya Bendsure BPharm
Reviewed By: Pharmacally Editorial Team
On October 20, 2025, the U.S. Food and Drug Administration (FDA) approved Roche’s Gazyva (Obinutuzumab), developed in partnership with Biogen, for the treatment of adult patients with active lupus nephritis who are already on standard therapy. The drug, marketed as Gazyva in the U.S. under Roche’s subsidiary Genentech, and co-commercialized with Biogen, marks a significant expansion beyond its oncology indications into autoimmune disease.
This approval is supported by strong efficacy and safety data from the Phase II NOBILITY and Phase III REGENCY trials, which demonstrated clinically meaningful kidney protection and sustained disease remission. Following initial induction doses, Gazyva can be administered twice yearly, offering a convenient regimen aimed at long-term disease management.
About Gazyva (Obinutuzumab)
Gazyva (obinutuzumab) is a glycoengineered type II anti-CD20 monoclonal antibody that selectively targets B lymphocytes responsible for driving autoimmune inflammation. It is originally approved in 2013 for chronic lymphocytic leukemia and later for follicular lymphoma; this new indication extends its therapeutic reach to autoimmune kidney disease. By depleting pathogenic B cells while maintaining immune balance, Gazyva interrupts the cycle of immune complex deposition and renal inflammation a primary contributor to lupus nephritis progression.
About the Disease: Lupus Nephritis
Lupus nephritis is a serious kidney problem that happens in people with systemic lupus erythematosus (SLE), an autoimmune disease where the immune system attacks the body’s own tissues. It affects about 1.7 million people worldwide, mostly women of color during their childbearing years.
In lupus nephritis, the immune system creates antibodies that damage the tiny filters in the kidneys. This causes inflammation, making it harder for the kidneys to remove waste and excess fluid properly. As a result, people may develop protein in the urine, high blood pressure, and swelling in different parts of the body.
If not treated well, the condition can lead to kidney failure, requiring dialysis or a kidney transplant. Even with existing treatments, up to one-third of people with lupus nephritis may eventually lose normal kidney function, showing the urgent need for better therapies.
Clinical Evidence: NOBILITY and REGENCY Trials
Study Design
NOBILITY (Phase II) and REGENCY (Phase III) were global, randomized, double-blind, placebo-controlled trials evaluating Gazyva plus standard lupus nephritis therapy (mycophenolate mofetil and glucocorticoids) compared with standard therapy alone.
The primary endpoint was the rate of complete renal response (CRR) at 76 weeks, defined by normalized proteinuria (UPCR < 0.5), preserved eGFR (≥85% baseline), and no rescue therapy use.
Key Findings
46.4% of patients receiving Gazyva achieved a complete renal response, compared with 33.1% on standard therapy alone.
Significant improvements were seen in complement levels, anti-dsDNA antibody reduction, and lower corticosteroid dependency.
These benefits translated into a clinically meaningful delay in disease progression and kidney failure prevention.
Safety Profile
Gazyva maintained a safety profile consistent with its established use in hemato-oncology, with no new or unexpected adverse effects reported in the lupus nephritis population. The most frequently observed side effects included mild-to-moderate infusion-related reactions, transient neutropenia, and respiratory infection risk. Importantly, the approval includes an updated labeling permitting a 90-minute infusion time after the initial dose, enhancing convenience and reducing clinic burden.
Expert Opinions
Dr. Levi Garraway, Roche’s Chief Medical Officer, stated that the approval “marks an important step toward a new standard of care in lupus nephritis,” underscoring Gazyva’s potential to preserve long-term kidney function. Louise Vetter, CEO of the Lupus Foundation of America, emphasized that this therapy “offers renewed hope” for patients living with the chronic burden of kidney inflammation and fatigue.
Implications for Public Health
The FDA’s approval of Gazyva provides much needed therapeutic advancement for lupus nephritis one of the leading causes of autoimmune kidney failure. The ability to achieve durable renal remission while minimizing corticosteroid exposure could improve patient quality of life and reduce progression to dialysis or transplant dependence.
By expanding an oncology-proven biologic into immunology, Roche and Biogen have paved the way for cross-disciplinary use of B-cell-directed therapies in complex autoimmune conditions, potentially reshaping the treatment landscape for lupus-related renal disease.
References
FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis, Roche, 20 October 2025, https://www.roche.com/media/releases/med-cor-2025-10-20
FDA Approves Genentech’s Gazyva for the Treatment of Lupus Nephritis, Genentech, 19 October 2025, https://www.gene.com/media/press-releases/15085/2025-10-19/fda-approves-genentechs-gazyva-for-the-t