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Gazyva/Gazyvaro, an anti-CD20 monoclonal antibody, demonstrated a complete renal response benefit in a Phase III study.
March 5, 2025
By: Rachel Klemovitch
Assistant Editor
Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) to treat lupus nephritis. The filing acceptance is based on results from the phase III REGENCY study, which showed improved complete renal response (CRR) with Gazyva/Gazyvaro plus standard therapy compared to standard therapy. The FDA is expected to decide on approval by October 2025. The phase III REGENCY study show...
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