The FDA granted Roche an additional indication for Gazyva (obinutuzumab), approving the CD20-targeting antibody for treatment of lupus nephritis. The approval expands the agent's use beyond hematologic malignancies and positions Roche against an established GSK biologic in a high-need autoimmune kidney indication. Company statements and regulatory materials emphasize Gazyva’s mechanism and clinical efficacy data supporting renal outcomes; payers and nephrology groups will now assess how the new label shifts treatment algorithms. The move also underscores the cross-indication potential for oncology-origin biologics in immune-mediated diseases.