Venclyxto

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venetoclax

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 18/01/2023

Authorisation details

Product details
Name
Venclyxto
Agency product number
EMEA/H/C/004106
Active substance
Venetoclax
International non-proprietary name (INN) or common name
venetoclax
Therapeutic area (MeSH)
Leukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code
L01XX52
Additional monitoringAdditional monitoring

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.

Publication details
Marketing-authorisation holder
AbbVie Deutschland GmbH Co. KG
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
04/12/2016
Contact address

Knollstrasse
67061 Ludwigshafen
Germany

Product information

20/10/2022 Venclyxto - EMEA/H/C/004106 - II/0042

Other EU languages available icon 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:

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.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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