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).

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.

This EPAR was last updated on 05/12/2018

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 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.

Conditional approval

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.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
AbbVie Deutschland GmbH Co. KG
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
04/12/2016
Contact address
Knollstrasse
67061 Ludwigshafen
Germany

Product information

20/11/2018 Venclyxto - EMEA/H/C/004106 - II/0011

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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