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.”

  1. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP) Opinion, Venclyxto, 13thOctober 2016.
  2. 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
  3. PharmaTimes Online. December 8th [Accessed December 12th 2016].



Download this article:

You can now download this article in Adobe PDF® format.

Download as PDF