On 21 April 2026, Roche announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE). According to Roche, if Gazyva®/Gazyvaro® is approved, it will be the first anti-CD20 therapy to directly target B cells in SLE.
The sBLA was based on positive results from the Phase III ALLEGORY trial, which was a double-blind, placebo-controlled parallel-group study with 303 patients. The Phase III results demonstrated significant reduction in disease activity compared to a placebo in patients with SLE. The safety was consistent with the previously characterised profile of Gazyva®/Gazyvaro®.
Gazyva®/Gazyvaro® was FDA-approved in October 2025 for the treatment of active lupus nephritis (LN) in eligible adult patients. The product is also approved in 100 countries for the treatment of haematological cancers.