Roche Gazyva application accepted by USFDA for lupus nephritis
Gazyva/Gazyvaro is an anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a CRR benefit in lupus nephritis.
Basel: Roche has announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis.
The filing acceptance is based on positive results from the phase III REGENCY study, which showed improved complete renal response (CRR) with Gazyva/Gazyvaro plus standard therapy compared with standard therapy alone. The FDA is expected to make a decision on approval by October 2025.
“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, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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.”
“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, Lupus Foundation of America. “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.”
The phase III REGENCY results, which were simultaneously presented at the World Congress of Nephrology (WCN) and published in the New England Journal of Medicine in February 2025, showed that nearly half of patients on Gazyva/Gazyvaro plus standard therapy achieved a CRR, with a statistically significant and clinically meaningful improvement, compared with standard treatment alone. This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, markers of disease activity and inflammation. A pre-specified subgroup analysis showed consistent CRR benefit across patient subgroups, highlighting treatment potential for a broad patient population with a high unmet need. Gazyva/Gazyvaro’s safety profile was consistent with the well-characterised profile observed in its haematology-oncology indications.
Data from the phase III REGENCY study are also being used for a filing submission with the European Medicines Agency.
Gazyva/Gazyvaro is an anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a CRR benefit in lupus nephritis. In 2019, Gazyva/Gazyvaro was granted Breakthrough Therapy Designation by the FDA based on data from the phase II NOBILITY study. In addition to REGENCY, Gazyva/Gazyvaro is being investigated in children and adolescents with lupus nephritis, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus (SLE), an autoimmune disease that commonly affects the kidneys and can lead to lupus nephritis.
The company's pipeline in immunological kidney and related diseases also includes Sefaxersen (ASO factor B), an antisense oligonucleotide therapy being investigated in people with primary immunoglobulin A nephropathy at high risk of progression, Lunsumio (mosunetuzumab), a first-in-class CD20xCD3 T-cell engaging bispecific antibody being investigated in SLE, PiaSky (crovalimab), a novel recycling monoclonal antibody being investigated in atypical haemolytic uraemic syndrome, RG6382, a CD19xCD3 T-cell engaging bispecific antibody being investigated in SLE, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T.
