AbbVie receives CHMP backing for EU approval of Venclyxto

AbbVie has announced that its new cancer therapy Venclyxto has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion recommending the tablet-based therapy for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation, among adult patients who cannot benefit from B-cell receptor pathway inhibitor therapy.

The drug – developed in collaboration with Genentech – is also recommended 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.

If granted conditional marketing authorisation by the European Commission, the venetoclax-based treatment would become the first approved BCL-2 inhibitor in Europe.

Dr Michael Severino, executive vice-president of research and development and chief scientific officer at AbbVie, said: "This innovation delivers on AbbVie's promise to develop cancer medicines where an unmet need exists. We will continue to work with European regulators to make venetoclax available to appropriate chronic lymphocytic leukaemia patients."

The therapy remains under evaluation by health authorities in multiple countries and is currently approved in Argentina, Puerto Rico and Canada.

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