EU CHMP recommends approval of Venclyxto (venetoclax) for chronic lymphocytic leukaemia- AbbVie
The EU's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Venclyxto (venetoclax), from AbbVie, intended for the treatment of chronic lymphocytic leukaemia (CLL). Venclyxto was designated as an orphan medicinal product on 6 December 2012. Venclyxto will be available as 10-mg, 50-mg and 100-mg film-coated tablets.
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.
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