Table of contents
Venclyxto is a cancer medicine used to treat adults with the following blood cancers:
- chronic lymphocytic leukaemia (CLL).
- acute myeloid leukaemia (AML).
For 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.
For AML, Venclyxto is used in combination with either azacitidine or decitabinein adults who cannot have intensive chemotherapy.
Venclyxto contains the active substance venetoclax.
Venclyxto : EPAR - Medicine overview (PDF/152.7 KB)
First published: 21/12/2016
Last updated: 25/06/2021
Venclyxto : EPAR - Risk-management-plan summary (PDF/90.31 KB)
First published: 06/11/2018
Last updated: 18/01/2023
|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 is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
AbbVie Deutschland GmbH Co. KG
|Date of issue of marketing authorisation valid throughout the European Union||
20/10/2022 Venclyxto - EMEA/H/C/004106 - II/0042
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).
Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
Venclyxto monotherapy is indicated for the treatment of 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, or
- in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
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