FDA Accepts Gazyva sBLA for Lupus Nephritis Treatment
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) in the treatment of lupus nephritis. This acceptance follows positive results from the Phase III REGENCY study, which demonstrated improved complete renal response (CRR) with Gazyva combined with standard therapy, compared to standard therapy alone. The FDA is expected to make its decision on approval by October 2025.
Lupus nephritis, a potentially life-threatening condition caused by systemic lupus erythematosus (SLE), can lead to severe kidney damage, kidney failure, and in some cases, the need for dialysis or kidney transplantation. It is a chronic autoimmune disease that particularly affects young women. Individuals with lupus nephritis often experience long-term disease-related complications, resulting in decreased quality of life. As such, the need for more effective treatments for this debilitating condition is critical.
Dr. Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Genentech, stated, “In people with lupus nephritis, Gazyva demonstrated a complete renal response benefit, a meaningful clinical outcome linked to preservation of kidney function and slowing or prevention of end-stage kidney disease. The FDA’s sBLA acceptance for Gazyva recognizes the need to provide a more effective treatment option for people living with this devastating disease.”
The Phase III REGENCY study, which was presented at the World Congress of Nephrology (WCN) and published in the New England Journal of Medicine in February 2025, showed that nearly 50% of patients treated with Gazyva in combination with standard therapy achieved a CRR, compared to those who received only standard therapy. The results demonstrated statistically significant and clinically meaningful improvements. Additionally, the treatment led to reductions in anti-dsDNA antibodies and improvements in complement levels, both of which are markers of disease activity and inflammation. These findings reinforce Gazyva’s potential as a treatment for a broad patient population with a high unmet need in lupus nephritis.
A pre-specified subgroup analysis within the REGENCY study also revealed that the CRR benefit was consistent across various patient subgroups, further indicating the broad applicability of the treatment. The safety profile of Gazyva in lupus nephritis patients was consistent with its established safety record from previous hematology-oncology indications, providing confidence in its use in this new therapeutic area.
Lupus nephritis is a critical condition that demands new therapeutic options. Louise Vetter, President and CEO of the Lupus Foundation of America, emphasized the importance of finding effective treatments: “Lupus nephritis is a debilitating and potentially life-threatening condition that can lead to kidney failure and require dialysis or transplantation. Given the relatively young age of onset, people with lupus nephritis experience more years of disease-related complications and decreased quality of life. We are hopeful for a new treatment option that can effectively reduce these risks and improve the health of all people affected by this disease.”
Gazyva’s application for lupus nephritis treatment is being closely monitored across multiple regulatory bodies. The data from the Phase III REGENCY study will also be used for a submission to the European Medicines Agency (EMA). If approved, Gazyva will be the only anti-CD20 monoclonal antibody in a randomized Phase III study to show a CRR benefit in lupus nephritis.
The significance of Gazyva’s potential was recognized in 2019 when it was granted Breakthrough Therapy Designation by the FDA based on promising Phase II data from the NOBILITY study. In addition to the REGENCY study in lupus nephritis, Gazyva is being investigated for various other indications. It is currently being tested in children and adolescents with lupus nephritis, as well as in people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome, and SLE.
Genentech’s pipeline also includes several other promising therapies for immunological kidney diseases. These include Sefaxersen (ASO factor B), an antisense oligonucleotide therapy for primary immunoglobulin A nephropathy; Lunsumio® (mosunetuzumab), a first-in-class CD20xCD3 T-cell engaging bispecific antibody for systemic lupus erythematosus (SLE); PiaSky® (crovalimab), a novel recycling monoclonal antibody for atypical hemolytic uremic syndrome; RG6382, a CD19xCD3 T-cell engaging bispecific antibody for SLE; and P-CD19CD20-ALLO1, an allogeneic dual CAR-T therapy.
The acceptance of Gazyva’s sBLA for lupus nephritis treatment marks a significant step forward in the ongoing efforts to improve care for patients suffering from lupus nephritis. The results from the Phase III REGENCY study bring hope to individuals who have long faced limited treatment options and serve as a foundation for continued research and development in this area. As more effective treatments become available, the potential to reduce kidney damage and improve long-term outcomes for patients with lupus nephritis becomes a realistic goal.
If Gazyva is approved, it will represent a critical advancement in lupus nephritis treatment, offering patients a new option to manage this complex and potentially life-threatening disease.
