Roche's CD20 Monoclonal Antibody Gazyva Receives FDA Approval for First Non-Oncology Indication in Lupus Nephritis

On October 20, 2025, Roche announced, based on its重磅抗CD20 Monoclonal Antibody Gazyva/Gazyvaro (Obinutuzumab) Achieves Excellent Data in Phase I/II NOBILITY and Phase III REGENCY Studies, has been approved by the U.S. FDA for the treatment ofAdult patients with active lupus nephritis (LN), and for eligible patients, the infusion time can be shortened to 90 minutes after the first infusion.

The solution inAfter completing four initial infusions in the first year, it can be switched to maintenance dosing twice a year., offering patients a more convenient and effective option than traditional targeted therapies.

The approval was primarily based on the Phase III REGENCY study, which demonstrated that, in combination with standard treatment (including mycophenolate mofetil + corticosteroids),46.4% of patients in the Gazyva/Gazyvaro group achieved complete renal response, compared to only 33.1% in the control group.. The differences were statistically significant, and the patients also showed clinically significant improvements in complement level enhancement, anti-dsDNA antibody reduction, decreased glucocorticoid dosage, and proteinuria improvement.The safety profile of Gazyva/Gazyvaro in hematological malignancies is consistent with what was observed in this study.。

Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Roche, stated: "For patients with lupus nephritis, achieving a complete renal response (CRR) makes it more likely to preserve kidney function and delay or even prevent progression to end-stage renal disease. The FDA’s approval of Gazyva/Gazyvaro marks an important step in establishing a new standard of care for this condition, providing clinicians with a more powerful tool for disease control."

Approximately 1.7 million people worldwide are affected by lupus nephritis, which primarily impacts women of childbearing age, especially women of color; if not effectively controlled, about one-third of patients may progress to end-stage renal disease, requiring dialysis or kidney transplantation.

As early as 2019, Gazyva/Gazyvaro received FDA Breakthrough Therapy designation based on the results of the Phase II NOBILITY study, which also laid the foundation for its expansion into the lupus nephritis field. The company is currently exploring the drug's applications in systemic lupus erythematosus, membranous nephropathy, and pediatric and adolescent lupus nephritis.

Gazyva/Gazyvaro is a type II engineered humanized anti-CD20 monoclonal antibody.By targeting CD20-positive B cells, it blocks their role in driving persistent inflammation and damaging kidney function in lupus nephritis. By depleting pathogenic B cells, the drug aims to intervene earlier in the process of kidney damage, protecting renal function from further deterioration. It is well-known that Gazyva/Gazyvaro has been approved for various types of hematological malignancies and is marketed in over 100 countries worldwide.

It is worth emphasizing that this approval also includes the possibility for eligible patients to shorten the infusion time to 90 minutes, which is expected to greatly enhance the convenience of treatment for patients and reduce the burden on medical resources. "This approval not only brings new hope for the treatment of patients with lupus nephritis but also marks an important advancement for Roche in the field of immune kidney disease.

References

https://www.roche.com/media/releases/med-cor-2025-10-20

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