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Venclyxto® (venetoclax) granted EMA approval, first approved BCL-2 inhibitor in Europe
Venclyxto® (venetoclax) has been granted EMA approval for use in treating adult patients with R/R CLL. This announcement follows the previously reported positive opinion given by the EMA CHMP for Venclyxto® in treatment of R/R CLL with 17p deletion or TP53 mutation in patients who are unsuitable for, or have failed, B-cell receptor pathway inhibitor based therapies, and for patients without these genetic changes who have failed both B-cell receptor pathway inhibition and chemoimmunotherapy.
Venclyxto® has therefore become the first BCL-2 inhibitor to be approved in Europe following the results of clinical trials into its use in patients with CLL. The full indication is as follows:
“Venclyxto® monotherapy is indicated for the treatment of chronic lymphocytic leukaemia (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.
Venclyxto® monotherapy is indicated for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.”
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