Conditional European marketing approval for Venclyxto in CLL

Following a positive recommendation in October from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the European Commission (EC) has now granted conditional marketing authorization for Venclyxto (venetoclax) monotherapy.

The approval for the AbbVie (NYSE: ABV) drug is for the treatment of chronic lymphocytic leukemia (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.

Analysts on average estimate the drug could generate peak annual sales of $1.7 billion, according to Thomson Reuters data.