The FDA expanded approval for Roche’s CD20-targeting antibody Gazyva to include lupus nephritis, the company announced. Gazyva was previously approved in oncology and now gains a new autoimmune indication, positioning Roche to compete directly with an existing GSK biologic standard of care for the kidney manifestation of systemic lupus erythematosus. Roche emphasized the label extension as a strategic push into immunology, leveraging Gazyva’s B‑cell depleting mechanism to address renal inflammation in lupus patients. The decision provides clinicians a new CD20 option for a disease with limited biologic choices and will affect treatment algorithms and payer discussions for lupus nephritis.