Venclyxto

venetoclax

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This is a summary of the European public assessment report (EPAR) for Venclyxto. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Venclyxto.

For practical information about using Venclyxto, patients should read the package leaflet or contact their doctor or pharmacist.

What is Venclyxto and what is it used for?

Venclyxto is a medicine for treating a blood cancer known as chronic lymphocytic leukaemia (CLL) when other treatments have failed or are unsuitable.

In patients with particular genetic changes (17p deletion or TP53 mutation) that make them unsuitable for chemo-immunotherapy, Venclyxto is used when medicines known as B‑cell receptor pathway inhibitors (ibrutinib and idelalisib) are not suitable or have failed.

In patients who do not have these genetic changes, Venclyxto is used after treatments with chemo-immunotherapy and a B‑cell receptor pathway inhibitor has failed.

Because the number of patients with CLL is low, the disease is considered ‘rare’, and Venclyxto was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 6 December 2012.

Venclyxto contains that active substance venetoclax.

How is Venclyxto used?

Venclyxto is available as tablets to be taken by mouth once a day with a meal. The starting dose is 20 mg daily and the dose is gradually increased over 5 weeks to 400 mg. The patient should stay on treatment for a long as the patient improves or remains stable and the side effects are tolerable. If the patient experiences certain side effects, treatment may be stopped temporarily or the dose reduced.

Venclyxto should be started and supervised by a doctor with experience of cancer medicines and can only be obtained with a prescription.

How does Venclyxto work?

The active substance in Venclyxto, venetoclax, attaches to a protein called Bcl-2. This protein is present in high amounts in CLL cancer cells, where it helps the cells survive for longer in the body and makes them resistant to cancer medicines. By attaching to Bcl-2 and blocking its actions, venetoclax causes the death of cancer cells and thereby slows the progression of the disease.

What benefits of Venclyxto have been shown in studies?

Studies have shown that a high proportion of patients have their cancer cells partially or completely cleared following treatment with Venclyxto. In a main study of 107 previously treated patients with CLL and 17p deletion, 75% responded partially or completely to Venclyxto. In another study of 64 patients with or without 17p deletion or TP53 mutation, the response rate was 67%. Patients in this second study had all previously taken B‑cell receptor pathway inhibitors.

What are the risks associated with Venclyxto?

The most common side effects with Venclyxto (seen in more than 1 in 5 people) are reduced neutrophils (a type of white blood cell), diarrhoea, nausea, anaemia (low red blood cell counts), nose and throat infection, tiredness, high levels of phosphate in the blood, vomiting and constipation.

The most common serious side effects (seen in more than 2 in 100 people) are pneumonia (lung infection), fever associated with reduced neutrophils and tumour lysis syndrome (a complication caused by breakdown of cancer cells). For the full list of side effects reported with Venclyxto, see the package leaflet.

Venclyxto must not be used with medicines known as ‘strong CYP3A inhibitors’ during the early stages of treatment and must also not be used with St. John’s wort (a herbal preparation used to treat anxiety and depression).

Why is Venclyxto approved?

A high proportion of patients respond to Venclyxto after other treatments have failed or are unsuitable.Studies showed patients with particular genetic mutations (17p deletion or TP53 mutations) that make them unsuitable for chemo-immunotherapy responding well to treatment. In addition, a high response rate was seen in patients whose previous treatment with ibrutinib or idelalisib failed.

Regarding safety, the medicine’s side effects are considered acceptable. Although there is a risk of tumour lysis syndrome, a complication that occurs when the cancer cells are being destroyed too quickly, this risk can be contained through preventive measures, such as increasing the dose gradually or reducing the dose, if needed.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that although a small number of patients have been studied so far Venclyxto's benefits outweigh its risks and recommended its approval in the EU.

Venclyxto has been given ‘conditional approval’. This means that there is more evidence to come about the medicine. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Venclyxto?

As Venclyxto has been granted a conditional approval, the company that markets the medicine will provide further data on its benefits and risks from an ongoing study of patients whose previous treatment with ibrutinib or idelalisib had failed.

What measures are being taken to ensure the safe and effective use of Venclyxto?

The company that markets Venclyxto will provide more data on the medicine’s overall safety. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Venclyxto have also been included in the summary of product characteristics and the package leaflet.

Other information about Venclyxto

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Venclyxto on 5 December 2016.

For more information about treatment with Venclyxto, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The summary of the opinion of the Committee for Orphan Medicinal Products for Venclyxto can be found on the Agency’s website.

Name Language First published Last updated
Venclyxto : EPAR - Summary for the public BG = bălgarski 2016-12-21  
Venclyxto : EPAR - Summary for the public ES = español 2016-12-21  
Venclyxto : EPAR - Summary for the public CS = čeština 2016-12-21  
Venclyxto : EPAR - Summary for the public DA = dansk 2016-12-21  
Venclyxto : EPAR - Summary for the public DE = Deutsch 2016-12-21  
Venclyxto : EPAR - Summary for the public ET = eesti keel 2016-12-21  
Venclyxto : EPAR - Summary for the public EL = elliniká 2016-12-21  
Venclyxto : EPAR - Summary for the public EN = English 2016-12-21  
Venclyxto : EPAR - Summary for the public FR = français 2016-12-21  
Venclyxto : EPAR - Summary for the public IT = italiano 2016-12-21  
Venclyxto : EPAR - Summary for the public LV = latviešu valoda 2016-12-21  
Venclyxto : EPAR - Summary for the public LT = lietuvių kalba 2016-12-21  
Venclyxto : EPAR - Summary for the public HU = magyar 2016-12-21  
Venclyxto : EPAR - Summary for the public MT = Malti 2016-12-21  
Venclyxto : EPAR - Summary for the public NL = Nederlands 2016-12-21  
Venclyxto : EPAR - Summary for the public PL = polski 2016-12-21  
Venclyxto : EPAR - Summary for the public PT = português 2016-12-21  
Venclyxto : EPAR - Summary for the public RO = română 2016-12-21  
Venclyxto : EPAR - Summary for the public SK = slovenčina 2016-12-21  
Venclyxto : EPAR - Summary for the public SL = slovenščina 2016-12-21  
Venclyxto : EPAR - Summary for the public FI = suomi 2016-12-21  
Venclyxto : EPAR - Summary for the public SV = svenska 2016-12-21  
Venclyxto : EPAR - Summary for the public HR = Hrvatski 2016-12-21  

This EPAR was last updated on 17/07/2017 .

Authorisation details

Product details

Product details for Venclyxto
NameVenclyxto
Agency product numberEMEA/H/C/004106
Active substance

venetoclax

International non-proprietary name (INN) or common name

venetoclax

Therapeutic area Leukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code L01XX52
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Venclyxto
Marketing-authorisation holder

AbbVie Ltd

Revision1
Date of issue of marketing authorisation valid throughout the European Union05/12/2016

Contact address:

AbbVie Ltd
Abbott House
Vanwall Business
Park Vanwall Road
Maidenhead
Berkshire SL6 4UB 
United Kingdom

Product information

Product information

28/04/2017  Venclyxto -EMEA/H/C/004106 -IA/004

Name Language First published Last updated
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17
Venclyxto : EPAR - Product Information HR = Hrvatski 2016-12-21 2017-07-17

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - All Authorised presentations HR = Hrvatski 2016-12-21  

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

Name Language First published Last updated
Venclyxto : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-07-17  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  
Venclyxto : EPAR - Conclusions on the granting of the conditional marketing authorisation HR = Hrvatski 2016-12-21  

Initial marketing-authorisation documents

Name Language First published Last updated
Venclyxto : EPAR - Public assessment report HR = Hrvatski 2016-12-21  
CHMP summary of positive opinion for Venclyxto HR = Hrvatski 2016-10-14  

Authorised

This medicine is approved for use in the European Union

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