As the lupus treatment landscape undergoes major changes, Roche is entering the US lupus nephritis market with a fresh FDA approval for its long-standing blood cancer drug, GAZYVA. On October 20, 2025, Roche’s Genentech division announced that the FDA had approved GAZYVA (obinutuzumab) for use in adults with active lupus nephritis who are already receiving standard therapy. Initially approved in 2013 for chronic lymphocytic leukemia (CLL), GAZYVA also holds approvals for treating follicular lymphoma across several settings. The treatment involves four initial infusions in the first year, followed by maintenance doses given twice a year.
Lupus nephritis is a serious...
