The FDA granted approval to Roche’s anti-CD20 antibody Gazyva for patients with lupus nephritis, expanding treatment options for a severe form of systemic lupus that affects the kidneys. Roche announced the approval and said it reflects positive pivotal data that supported a new renal indication. Clinicians and payers will now assess how Gazyva fits alongside existing immunosuppressants and biologics for this patient population. The approval may prompt updated guideline reviews and reimbursement discussions given the high unmet need in lupus nephritis.