Posted by Michael Wonder on 14 Oct 2016
AbbVie receives CHMP positive opinion for Venclyxto (venetoclax) tablets for appropriate patients with difficult-to-treat chronic lymphocytic leukaemia
14 October 2016 - If granted conditional marketing authorisation by the European Commission, Venclyxto would become the first approved BCL-2 inhibitor in Europe.
AbbVie today announced that the European CHMP has granted a positive opinion for Venclyxto (venetoclax) tablets 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 chemo-immunotherapy and a B-cell receptor pathway inhibitor.
The European Commission will review the opinion and make a final decision in late 2016. Venclyxto is being developed by AbbVie and Genentech, a member of the Roche Group.
