FDA Accepts Roche’s Supplemental Biologics License Application for Gazyva/Gazyvaro in Lupus Nephritis
Submission is supported by positive results from the Phase III REGENCY trial, which demonstrated that nearly half of patients with lupus nephritis who received Gazyva/Gazyvaro plus standard therapy achieved a complete renal response.
Image Credit: Adobe Stock Images/Jo Panuwat D
The FDA has accepted Roche’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis. The submission was based on positive results from the Phase III REGENCY trial, in which nearly half of patients administered Gazyva/Gazyvaro plus standard therapy achieved a complete renal response (CRR).1
“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, head, global product development, Roche, in a press release. “The FDA’s sBLA acceptance for Gazyva/Gazyvaro recognizes the need to provide a more effective treatment option for people living with this devastating disease.”
The randomized, double-blind, placebo-controlled, multicenter REGENCY trial evaluated the safety and efficacy of Gazyva/Gazyvaro in addition to standard therapy in patients with lupus nephritis. During the trial, 271 patients were randomly assigned in a 1:1 ratio to receive either Gazyva/Gazyvaro plus standard therapy or placebo plus standard therapy. The primary endpoint of the study was CRR, with key secondary endpoints that included a reduction in corticosteroid use, improvements in proteinuric response at 76 weeks, mean change in estimated glomerular filtration rate at 76 weeks, and overall renal response at 50 weeks.
Results demonstrated that 46.4% of patients in the Gazyva/Gazyvaro arm achieved CRR at 76 weeks, compared to 33.1% in the placebo arm. Additionally, the treatment demonstrated promise in reducing corticosteroid use and improving proteinuric response at 76 weeks. However, mean change in estimated glomerular filtration rate and overall renal response were not found to be statistically significant. Gazyva/Gazyvaro’s safety profile remained consistent with its established use in hematology and oncology.1 Most adverse events were infections related to COVID-19 and were more common in patients treated with Gazyva/Gazyvaro.2
According to Medscape, around 50% to 60% of patients with systemic lupus erythematosus (SLE) show signs of lupus nephritis.3 According to ZyVersa Therapeutics, lupus nephritis affects anywhere from 80,000 to 100,000 patients in the United States and one million globally, making it an orphan disease.4
According to the Centers for Disease Control and Prevention, over 200,000 people in the United States are currently living with SLE. Women are much more likely to have it than men, with current data in the United States demonstrating 184,000 cases for females compared to 20,000 cases for males. Additionally, women of childbearing age have a higher risk of developing the condition, however, it can develop at any age. African American, Hispanic, Asian, American Indian, and Alaska Native patients are more likely to develop the disease than White patients. Black people diagnosed with SLE tend to die at a much younger age than White patients. In most cases, White patients live more than 10 years longer.5
“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, CEO, Lupus Foundation of America, in the press release. “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.”
A final decision by the FDA is expected in October.1
References
1. FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis. Roche. March 4, 2025. Accessed March 5, 2025. https://www.roche.com/media/releases/med-cor-2025-03-05
2. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. The New England Journal of Medicine. February 7, 2025. Accessed March 5, 2025. https://www.nejm.org/doi/full/10.1056/NEJMoa2410965
3. Lupus Nephritis. Medscape. Accessed March 5, 2025. https://emedicine.medscape.com/article/330369-overview
4. About Lupus nephritis. ZyVersa. Accessed March 5, 2025. https://www.zyversa.com/pipeline/about-lupus-nephritis#:~:text=Lupus%20nephritis%20is%20considered%20an,within%205%20years%20of%20diagnosis.
5. People with Lupus. CDC. Accessed March 5, 2025. https://www.cdc.gov/lupus/data-research/index.html#:~:text=Systemic%20lupus%20erythematosus%20(SLE)%20is,more%20likely%20to%20develop%20SLE.
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