NICE recommends Venclyxto plus Rituxan in chronic lymphocytic leukaemia.- AbbVie + Genentech/Roche

The National Institute for Health and Care Excellence (NICE) has recommended Venclyxto (venetoclax) with Rituxan (rituximab), from AbbVie + Genentech/Roche, for adults with relapsed or refractory chronic lymphocytic leukaemia. This positive response comes despite the first NICE committee meeting which took place in September 2018, when the committee decided that ncertainties with clinical evidence and economic modelling led it to reject the drug.

Comment: Venclyxto was previously granted conditional marketing authorisation in the EU in December 2016 as a single agent for the treatment of CLL in the presence of 17p deletion or TP53 mutation in people who are unsuitable for or have failed a B-cell receptor pathway inhibitor. The EU approval in November 2018 follows the FDA approval in June 2018 of Venclexta in combination with Rituxan for the treatment of people with CLL or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. Additional submissions of the MURANO data to health authorities around the world are ongoing.