European Commission approves Venclyxto plus Gazyvaro for adults with previously untreated chronic lymphocytic leukaemia

Basel, 12 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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 leukaemia (CLL).“Venclyxto plus Gazyvaro is the first fixed-duration, chemotherapy-free treatment option that has been shown to help patients with untreated chronic lymphocytic leukaemia live longer without their disease progressing,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This is an important step forward for adults with this disease in the EU, who will now have an effective treatment option that enables them to end treatment after one year.” The approval is based on results from the primary analysis of the pivotal phase III CLL14 study, which evaluated the combination of 12-month, fixed-duration Venclyxto plus Gazyvaro compared to Gazyvaro plus chlorambucil in adults with previously untreated CLL who had co-existing medical conditions. Results from the primary analysis showed that the combination of Venclyxto plus Gazyvaro led to a 65% reduction in the risk of disease worsening or death (progression-free survival [PFS], as assessed by investigators) compared to Gazyvaro plus chlorambucil, a current standard-of-care for CLL (HR=0.35; 95% CI 0.23-0.53; p<0.0001). When PFS was assessed by an independent review committee, this finding w...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news