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 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.

This EPAR was last updated on 07/05/2020

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
10
Date of issue of marketing authorisation valid throughout the European Union
04/12/2016
Contact address
Knollstrasse
67061 Ludwigshafen
Germany

Product information

08/04/2020 Venclyxto - EMEA/H/C/004106 - PSUSA/00010556/201906

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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