The FDA approved Roche’s CD20 antibody Gazyva for treatment of lupus nephritis, expanding the drug’s label beyond oncology and providing an alternative biologic for patients with autoimmune kidney disease. Roche and regulatory filings describe the approval and position Gazyva as a competitor to existing agents in the indication. Company statements and press coverage highlighted the clinical data supporting efficacy and safety in renal lupus populations; Roche will now begin commercial and medical affairs activities to support launch and payer discussions. Nephrology and rheumatology clinicians will assess how Gazyva fits into current treatment pathways, reimbursement scenarios and head‑to‑head positioning versus incumbent biologics.