WESTON (dpa-AFX) - Genentech, a member of the Roche Group (RHHBY), announced that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application or sBLA for Gazyva (obinutuzumab) for the treatment of lupus nephritis.
The filing acceptance is based on positive results from the Phase III REGENCY study, which showed improved complete renal response (CRR) with Gazyva plus standard therapy compared with standard therapy alone.The FDA is expected to make a decision on approval by October 2025.
Gazyva is already approved in 100 countries for various types of lymphoma.
In the United States, Gazyva is part of a collaboration between Genentech and Biogen.
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