The FDA granted approval for Roche’s CD20 antibody Gazyva to treat lupus nephritis, marking a new indication for the company’s marketed antibody. Roche said the approval expands therapeutic options for a kidney‑involving form of systemic lupus erythematosus. Roche framed the decision as an extension of Gazyva’s clinical utility beyond oncology and hematology, bringing a targeted B‑cell approach into a serious autoimmune renal indication where treatment choices are limited. Regulatory details and label specifics will shape adoption and payer discussions.