Venclyxto is a cancer medicine used to treat adults with a blood cancer known as chronic lymphocytic leukaemia (CLL).
Venclyxto can be used in combination with rituximab (another cancer medicine) in patients who have received at least one previous treatment.
It can also be used on its own in:
- patients with particular genetic changes (17p deletion or TP53 mutation) that make them unsuitable for chemo-immunotherapy (a type of cancer treatment). In these patients, Venclyxto is used when medicines known as B‑cell receptor pathway inhibitors (ibrutinib and idelalisib) are not suitable or have failed.
- patients who do not have these genetic changes after treatments with chemo-immunotherapy and a B‑cell receptor pathway inhibitor have both failed.
Venclyxto contains that active substance venetoclax.
Venclyxto : EPAR - Medicine overview (PDF/83.85 KB)
First published: 21/12/2016
Last updated: 05/12/2018
Venclyxto : EPAR - Risk-management-plan summary (PDF/111.39 KB)
First published: 06/11/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Leukemia, Lymphocytic, Chronic, B-Cell
|Anatomical therapeutic chemical (ATC) code||
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
AbbVie Deutschland GmbH Co. KG
|Date of issue of marketing authorisation valid throughout the European Union||
20/11/2018 Venclyxto - EMEA/H/C/004106 - II/0011
- 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
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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.