Roche announced the FDA has accepted its application for Gazyva/Gazyvaro for systemic lupus erythematosus (SLE), based on positive phase III ALLEGORY data. The ALLEGORY study showed Gazyva/Gazyvaro significantly reduced disease activity compared to placebo, measured by the SRI-4 at 52 weeks. The FDA is expected to make an approval decision by December 2026. Gazyva/Gazyvaro is already approved for lupus nephritis in the US and EU. The study also demonstrated improvements in secondary endpoints, like BICLA response and glucocorticoid reduction. Patients on Gazyva/Gazyvaro were less likely to experience flares and showed higher remission rates. The safety profile of Gazyva/Gazyvaro was consistent with previous findings. Gazyva/Gazyvaro targets B cells, and could become a new standard of care for SLE, affecting millions. The ALLEGORY data has also been submitted to the European Medicines Agency for review. This treatment offers hope for better disease control and reducing the burden of long-term steroid use.