The FDA granted approval for Roche’s CD20 antibody Gazyva (obinutuzumab) to treat lupus nephritis, the company said. The decision adds a targeted B‑cell therapy to the limited toolkit for kidney‑involved systemic lupus erythematosus and follows Roche’s regulatory submissions supported by pivotal trial data. Roche framed the label as expanding treatment options for patients with renal involvement of lupus, citing clinical trial endpoints used in its filing. The approval removes a barrier to broader use of anti‑CD20 approaches in autoimmune nephritis and will reshape market access and payer discussions for high‑cost biologics in this indication.