FDA Accepts Obinutuzumab (Gazyva/Gazyvaro) sBLA for Lupus Nephritis

Louise Vetter

Credit: Lupus Foundation of America

Roche has announced the US Food and Drug Administration (FDA) acceptance of the company’s supplemental Biologics License Application (sBLA) for obinutuzumab (Gazyva/Gazyvaro) for the treatment of lupus nephritis.¹

According to a March 5, 2025, press release from the company, the filing acceptance is based on positive results from the phase 3 REGENCY study, which showed improved complete renal response with obinutuzumab plus standard therapy compared with standard therapy alone. The FDA is expected to make a decision on approval by October 2025.¹

“Lupus nephritis is a debilitating and potentially life-threatening condition that can lead to kidney failure and require dialysis or transplantation,” said Louise Vetter, president and chief executive officer of the Lupus Foundation of America.¹ “Given the relatively young age of onset, people with lupus nephritis experience more years of disease-related complications and decreased quality of life due to the significant burden of this illness. 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.”

Obinutuzumab is a Type II engineered humanised monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells. In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys. By targeting disease-causing B cells with obinutuzumab, patients can gain better control of the disease, protect their kidneys from further damage, and potentially prevent or delay progression to end-stage kidney disease.¹

In 2019, obinutuzumab was granted Breakthrough Therapy Designation by the FDA based on data from the phase 2 NOBILITY study. In addition to REGENCY, obinutuzumab is being investigated in children and adolescents with lupus nephritis, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus.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.¹

Participants were randomly assigned in a 1:1 ratio to receive either biannual intravenous dosing of obinutuzumab plus standard therapy or placebo plus standard therapy.¹

For the primary endpoint of interest, use of obinutuzumab wasd associated with a statistically significant and clinically meaningful improvement in complete renal response, with 46.4% of patients achieving complete renal response at 76 weeks compared to just 33.1% of people treated with standard therapy alone (adjusted difference, 13.4%; 95% CI, 2.0 to 24.8; P = .0232). Investigators pointed out there were no unexpected safety signals identified in the trial, but more serious adverse events, mainly infections and events related to COVID-19, occurred among the obinutuzumab group.²

“In people with lupus nephritis, Gazyva/Gazyvaro 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,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche.¹ “The FDA’s sBLA acceptance for Gazyva/Gazyvaro recognises the need to provide a more effective treatment option for people living with this devastating disease.”

References

1. Roche. FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis. March 5, 2025. Accessed March 5, 2025. https://www.globenewswire.com/news-release/2025/03/05/3037102/0/en/FDA-accepts-supplemental-Biologics-License-Application-for-Roche-s-Gazyva-Gazyvaro-for-the-treatment-of-lupus-nephritis.html

2. Campbell P. REGENCY: Obinutuzumab Proves Efficacy in Lupus Nephritis. HCPLive. February 7, 2025. Accessed March 5, 2025. https://www.hcplive.com/view/regency-obinutuzumab-proves-efficacy-in-lupus-nephritis