Venclyxto is a cancer medicine used to treat adults with a blood cancer known as chronic lymphocytic leukaemia (CLL). It is used either in combination with other cancer medicines or on its own.
Venclyxto can be used with obinutuzumab in patients who have not previously been treated for CLL or with rituximab in patients who have received at least one previous treatment. Obinutuzumab and rituximab are immunotherapy medicines (medicines that act through the body’s defence system).
It can also be used on its own in:
- patients with particular genetic changes (17p deletion or TP53 mutation) who cannot be treated with medicines known as B‑cell receptor pathway inhibitors (ibrutinib and idelalisib) or if these medicines have stopped working.
- patients who do not have these genetic changes, after treatments with chemotherapy combined with immunotherapy as well as a B‑cell receptor pathway inhibitor have both not worked.
Venclyxto contains the active substance venetoclax.
Venclyxto : EPAR - Medicine overview (PDF/150.57 KB)
First published: 21/12/2016
Last updated: 07/05/2020
Venclyxto : EPAR - Risk-management-plan summary (PDF/103.49 KB)
First published: 06/11/2018
Last updated: 24/04/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Leukemia, Lymphocytic, Chronic, B-Cell
|Anatomical therapeutic chemical (ATC) code||
AbbVie Deutschland GmbH Co. KG
|Date of issue of marketing authorisation valid throughout the European Union||
08/04/2020 Venclyxto - EMEA/H/C/004106 - PSUSA/00010556/201906
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 202031/01/2020
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 201821/09/2018
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 201614/10/2016