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: Phase III REGENCY trial demonstrated 46.4% complete renal response vs 33.1% with standard therapy alone Significant improvement in multiple secondary endpoints including proteinuria reduction Consistent safety profile with known oncology indications First anti-CD20 monoclonal antibody with phase III evidence in lupus nephritis : - More convenient administration schedule: four initial doses in first year, then twice-yearly infusions - Option for 90-minute infusions after initial dose - Maintains standard therapy alongside biologic treatment - Requires monitoring for infections and infusion-related reactions "This approval provides a much-needed new option for these patients," said Levi Garraway, MD, PhD, chief medical officer at Roche, highlighting the significant unmet need in lupus nephritis management

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