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Venclyxto® (venetoclax) granted EMA approval, first approved BCL-2 inhibitor in Europe
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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.”
- European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP) Opinion, Venclyxto, 13thOctober 2016.
- Venetoclax in relapsed or refractory chronic lymphocytic leukaemia with 17p deletion: a multicentre, open-label, phase 2 study. Stilgenbauer, S. et al. The Lancet Oncology, Volume 17 , Issue 6 , 768 – 778
- PharmaTimes Online. December 8th http://www.pharmatimes.com/news/abbvies_venclyxto_okd_in_europe_for_cll_1180791 [Accessed December 12th 2016].
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