The FDA has approved Roche's Gazyva/Gazyvaro for active lupus nephritis in adults receiving standard therapy, based on the NOBILITY and REGENCY studies. Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to show a complete renal response benefit in a phase III lupus nephritis study. The REGENCY study showed a significantly higher complete renal response rate with Gazyva/Gazyvaro plus standard therapy compared to standard therapy alone. Eligible patients can now receive a shorter 90-minute infusion time after the first infusion, and a twice-yearly administration schedule after the initial doses. Lupus nephritis, affecting over 1.7 million people worldwide, disproportionately impacts women of colour. The approval offers renewed hope by potentially preventing long-term complications like kidney failure, and improves disease control. Gazyva/Gazyvaro targets CD20 on B cells, depleting disease-causing cells to limit kidney damage. The drug has also received a positive opinion from the European Medicines Agency and continues to be investigated for other kidney conditions. It is already approved in 100 countries for certain blood cancers and is a collaboration between Genentech and Biogen in the U.S.