EU approves Venclyxto (venetoclax) for chronic lymphocytic leukaemia- AbbVie

AbbVie announced the European Commission (EC) has granted conditional marketing authorization 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 EC approved Venclyxto (Venclexta in the US) 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 commercialized by the companies in the U.S. and by AbbVie outside of the U.S.

Comment: The benefits shown in single arm studies with Venclyxto are its ability to produce responses in patients unsuitable for or refractory to B-cell receptor pathway inhibitors and other anticancer medicines. The most common side effects are neutropenia / neutrophil count decreased, diarrhoea, nausea, anaemia, upper respiratory tract infection, fatigue, hyperphosphataemia, vomiting, and constipation.