Posted by Michael Wonder on 08 Dec 2016
European Commission grants conditional marketing approval for AbbVie's Venclyxto (venetoclax) monotherapy for appropriate patients with difficult-to-treat chronic lymphocytic leukaemia
8 December 2016 - Venclyxto is the first approved BCL-2 inhibitor in Europe.
AbbVie today announced the European Commission has granted conditional marketing authorisation for Venclyxto (venetoclax) monotherapy for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
The European Commission approved Venclyxto as a first-in-class, oral, once-daily medicine that selectively inhibits the function of the BCL-2 protein. BCL-2 prevents the natural death of cells, including CLL cells.
Venclyxto is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialised by the companies in the U.S. and by AbbVie outside of the U.S.
