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Roche : EC Oks Venclyxto-Gazyvaro For Adults With Chronic Lymphocytic Leukaemia

Roche (RHHBY) said that the European Commission has approved Venclyxto or venetoclax in combination with Gazyvaro or obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia or CLL.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US, under the brand name Venclexta, and commercialised by AbbVie outside of the US.

The approval was 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 compared to Gazyvaro plus chlorambucil, a current standard-of-care for CLL.

chronic lymphocytic leukaemia is a slow-growing form of leukemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow.

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