Roche's Gazyva Secures FDA Nod for Label Expansion in Lupus Nephritis

Key Takeaways FDA approves Roche's Gazyva for adults with active lupus nephritis receiving standard therapy.Approval based on strong phase II and III data showing significant renal response improvements.Patients can now receive shorter infusions and fewer annual doses, enhancing treatment convenience.Roche (RHHBY) announced that the FDA has approved a regulatory filing seeking the label expansion of Gazyva/Gazyvaro (obinutuzumab) to treat adult patients with active lupus nephritis (LN) who are receiving sta ...