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Home Industry News AbbVie receives conditional EU approval for Venclyxto

AbbVie receives conditional EU approval for Venclyxto

8th December 2016

AbbVie has announced that its cancer drug Venclyxto has received conditional marketing approval from the European Commission as a treatment for chronic lymphocytic leukaemia (CLL).

The drug has been authorised as a monotherapy for the treatment of CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unable to benefit from B-cell receptor pathway inhibitor treatment.

It has also been ratified for use in treating CLL in the absence of 17p deletion or TP53 mutations in adult patients who have failed both chemoimmunotherapy and B-cell receptor pathway inhibitor therapy.

This first-in-class, once-daily oral medicine works by selectively inhibiting the function of the BCL-2 protein, which prevents the natural death of cells. It has shown a strong overall response rate in several clinical trials.

Richard Gonzalez, chairman of the board and chief executive officer of AbbVie, said: "AbbVie has led the way in researching ways to block BCL-2 activity, and, as the first approved BCL-2 inhibitor in Europe, Venclyxto delivers on AbbVie's promise to develop cancer medicines where an unmet need exists."

The drug was developed by AbbVie and Roche subsidiary Genentech, and will be jointly commercialised by both companies in the US, with AbbVie handling international sales.

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