April 2020—Roche announced that the European Commission has approved Venclyxto (venetoclax) in combination with Gazyvaro (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia.
The approval is based on results from the primary analysis of the pivotal phase three CLL14 study, which evaluated the combination of 12-month, fixed-duration Venclyxto plus Gazyvaro compared with Gazyvaro plus chlorambucil in adults with previously untreated CLL who had coexisting medical conditions. Results from the primary analysis showed that the combination of Venclyxto plus Gazyvaro led to a 65 percent reduction in the risk of disease worsening or death compared with Gazyvaro plus chlorambucil, a current standard of care for CLL.
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