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FDA Accepts Supplemental Biologics Application for Gazyva® in Systemic Lupus Erythematosus
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application for Gazyva® (obinutuzumab) for adults with systemic lupus erythematosus (SLE). The filing draws on the positive results from the Phase III ALLEGORY study which met its primary endpoint, showing a clear, statistically significant, and clinically meaningful benefit. Gazyva was previously approved for the treatment of lupus nephritis (lupus-related kidney disease) in adults in October 2025.
The ALLEGORY study found nearly 77% of adults with moderate to severe SLE treated with Gazyva plus standard therapy achieved a clinically relevant improvement (≥4 point increase in SLE Responder Index-4 (a measure that assesses changes in disease severity, symptoms, and physical condition at 52 weeks, compared with about 54% in the placebo group. With FDA acceptance, Gazyva moves closer to becoming the first anti-CD20 therapy indicated for SLE, broadening its existing approvals in lupus nephritis, (LN, lupus-related kidney disease) and multiple blood cancers.
The FDA decision is expected by December 2026. Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about Gazyva.