The FDA approval marks Gazyva’s first non-oncology indication, expanding Roche’s presence into autoimmune disease treatment.
The anti-CD20 antibody, developed by Roche’s Genentech along with Biogen and already approved for multiple oncology indications, is branching into autoimmune disease. Its B cell–targeting mechanism of action gives it activity in improving kidney conditions in patients with lupus nephritis.
The FDA has approved Roche’s Gazyva, an anti-CD20 antibody already approved for certain blood cancers, to treat adults with lupus nephritis.
The greenlight, announced Monday, adds the drug’s first non-oncology indication. First approved in 2013 to treat chronic lymphocytic leukemia (CLL), Gazyva is also approved to treat follicular lymphoma in multiple settings.
The approval was based on data from two studies from Roche’s Genentech, the Phase II NOBILITY and Phase III REGENCY trials. In REGENCY, 46.4% of patients receiving Gazyva in combination with “standard therapy,” consisting of mycophenolate and steroids, achieved complete renal response, compared to 33.1% on standard therapy alone. The drug was co-developed by Genentech and Biogen.
Lupus nephritis is a manifestation of broader systemic lupus erythematosus, an autoimmune disease that often attacks the kidneys. Lupus nephritis leads to loss of nephrons, the underlying filtering microstructures in kidneys, with untreated patients progressing to renal failure requiring dialysis or transplant. Up to 30% of patients advance to end-stage kidney disease, according to the Lupus Research Alliance.
Gazyva is an engineered, humanized monoclonal antibody that targets CD20, a protein on the surface of some kinds of B cells, the immune cells that cause lupus-related kidney inflammation.
This is a major step forward for the entire lupus community, as it is the only anti-CD20 monoclonal antibody targeting an underlying cause of lupus nephritis,” the Lupus Research Alliance wrote in a statement commending the drug’s approval.
Standard of care for lupus nephritis is currently mycophenolate or cyclophosphamide, both immunosuppressants, as well as steroids.
People with lupus nephritis who achieve a complete renal response are more likely to experience preserved kidney function and delay, or even prevention, of progression to end-stage kidney disease,” Levi Garraway, Roche’s chief medical officer, said in the company’s announcement.
Gazyva is administered first as four initial doses in the first year a patient receives it, followed by a twice yearly regimen. That schedule, according to Roche, is a potentially more convenient option than “traditional targeted therapies.”
Roche is also testing Gazyva in patients with systemic lupus erythematosus as well as other renal conditions like membranous nephropathy, idiopathic nephrotic syndrome, and in children and adolescents with lupus nephritis.
The FDA’s decision is backed by data from two key clinical trials conducted by Roche’s Genentech: the Phase II NOBILITY and Phase III REGENCY studies. In REGENCY, 46.4% of patients who received Gazyva alongside standard therapy achieved a complete renal response, compared with 33.1% in those receiving standard therapy alone. The standard regimen typically includes mycophenolate mofetil and steroids, which are commonly used immunosuppressants for lupus nephritis.
People with lupus nephritis who achieve a complete renal response are more likely to preserve kidney function and delay, or even prevent, progression to end-stage kidney disease,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “This approval provides a much-needed, targeted treatment option for patients facing this life-threatening condition.”
Gazyva’s dosing regimen also offers convenience compared to existing therapies. Patients receive four initial infusions in the first year, followed by twice-yearly maintenance doses. Roche highlighted this as a more manageable approach than continuous immunosuppressive treatments, which often require ongoing oral or intravenous dosing.
Current standard-of-care treatments—such as mycophenolate, cyclophosphamide, and steroids—help control inflammation but can carry significant side effects and are not always effective in preventing disease progression. Gazyva’s approval adds a targeted biologic option designed to address the underlying immune dysfunction in lupus nephritis.
Beyond lupus nephritis, Roche is actively investigating Gazyva’s potential in other autoimmune and renal disorders, including systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and pediatric forms of lupus nephritis. These studies reflect Roche’s broader strategy to repurpose oncology assets for immune-mediated diseases, capitalizing on its deep experience in B-cell biology and antibody engineering.
The FDA’s approval of Gazyva for lupus nephritis marks a pivotal advance for both patients and the field of autoimmune medicine. For the lupus community—long underserved by limited, non-targeted therapies—the decision offers a promising new treatment pathway with the potential to preserve kidney function and improve long-term outcomes.
