Roche announced a positive recommendation from the CHMP for Gazyva/Gazyvaro, combined with mycophenolate mofetil, to treat adult lupus nephritis. This recommendation is based on phase II and III study results demonstrating Gazyva/Gazyvaro's superiority. In the REGENCY study, nearly half of the participants receiving the treatment achieved complete renal response. This treatment also showed a reduction in corticosteroid use alongside improved disease control. Gazyva/Gazyvaro is the only anti-CD20 antibody showing a complete renal response benefit in a phase III study for lupus nephritis. The safety profile aligns with its established use in other blood cancers. The FDA is expected to make a decision on approval in the US this year based on REGENCY data. Gazyva/Gazyvaro is currently being investigated for other diseases related to kidney. Lupus nephritis is a severe condition that affects millions globally, often leading to kidney failure. Roche aims to provide a new treatment option potentially preventing or delaying end-stage kidney disease.