Erivedge

vismodegib

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

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

What is Erivedge and what is it used for?

Erivedge is a cancer medicine that contains the active substance vismodegib. It is used to treat adults with basal cell carcinoma (a slow-growing form of skin cancer) in advanced stages: when the cancer is metastatic (has spread to other parts of the body) and is causing symptoms, or when it is locally advanced (has started to spread to nearby areas) and is not suitable for surgery or radiotherapy (treatment with radiation).

How is Erivedge used?

Erivedge can only be obtained with a prescription. It should only be prescribed by or under the supervision of a specialist doctor experienced in managing basal-cell carcinoma. It is available as capsules (150 mg). The recommended dose is one capsule once a day. The benefits of continuing treatment should be regularly assessed and the best duration of treatment will vary based on the benefit and side effects experienced by each patient. For further information, see the package leaflet.

How does Erivedge work?

The active substance in Erivedge, vismodegib, acts by disrupting the so-called ‘Hedgehog signalling pathway’, which is normally involved in regulating the early cell-development stages of unborn babies and in certain cell processes in adults. In basal cell carcinoma, the Hedgehog signalling pathway becomes abnormally active and leads to the growth and spread of the cancerous cells. Vismodegib attaches to a protein called ‘SMO’, which is involved in activating the Hedgehog signalling pathway. By attaching to SMO, vismodegib blocks this pathway, thereby slowing down the growth and spread of the cancer cells in basal cell carcinoma.

What benefits of Erivedge have been shown in studies?

Erivedge was studied in one main study involving 104 patients with either metastatic or locally advanced basal-cell carcinoma. The patients were given Erivedge until their disease got worse or they could no longer tolerate treatment or withdrew from the study. Erivedge was not compared with any other treatment. The main measure of effectiveness was the response to treatment, based on reduction by at least 30% in tumour size or disappearance of all signs of cancer (the objective response rate). Around 33% (11 out of 33) of patients with metastatic disease and 48% (30 out of 63) of patients with locally advanced disease responded to treatment.

What are the risks associated with Erivedge?

The most common side effects with Erivedge (seen in more than 3 in 10 people) are muscle spasms, alopecia (hair loss), dysgeusia (taste disturbances), weight loss, fatigue (tiredness), nausea (feeling sick) and diarrhoea. For the full list of all side effects reported with Erivedge, see the package leaflet.

Erivedge must not be used in women who are pregnant or breast-feeding, or who could potentially have children and do not comply with the special pregnancy prevention programme for Erivedge. It must not be used together with St John’s wort (a herbal medicine used to treat depression). For the full list of restrictions, see the package leaflet.

Why is Erivedge approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Erivedge’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee considered that the benefits of Erivedge had been shown for patients with locally advanced and metastatic disease. It also considered that the side effects were manageable, although the data on patients with metastatic disease were limited. Since Erivedge disrupts the mechanism involved in the early development stages of unborn babies, the CHMP concluded that appropriate measures were needed for both men and women treated with Erivedge to prevent pregnancy during and after stopping treatment.

Erivedge has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, which the company is required to provide. 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 Erivedge?

Since Erivedge has been granted a conditional approval, the company that markets Erivedge will provide the results of a large safety study in patients with metastatic disease.

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

A risk-management plan has been developed to ensure that Erivedge is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Erivedge, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company will implement a pregnancy-prevention programme, by providing educational materials on the risks to the unborn baby, including a reminder card, to patients and healthcare professionals who are expected to prescribe and dispense Erivedge. The company will report any pregnancies that occur during treatment with Erivedge and will monitor their outcome.

Other information about Erivedge

The European Commission granted a marketing authorisation valid throughout the European Union for Erivedge on 12 July 2013.

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

Name Language First published Last updated
Erivedge : EPAR - Summary for the public BG = bălgarski 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public ES = español 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public CS = čeština 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public DA = dansk 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public DE = Deutsch 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public ET = eesti keel 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public EL = elliniká 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public EN = English 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public FR = français 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public IT = italiano 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public LV = latviešu valoda 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public LT = lietuvių kalba 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public HU = magyar 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public MT = Malti 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public NL = Nederlands 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public PL = polski 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public PT = português 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public RO = română 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public SK = slovenčina 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public SL = slovenščina 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public FI = suomi 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public SV = svenska 30/07/2013 16/02/2015
Erivedge : EPAR - Summary for the public HR = Hrvatski 30/07/2013 16/02/2015

This EPAR was last updated on 12/07/2016 .

Authorisation details

Product details

Product details for Erivedge
NameErivedge
Agency product numberEMEA/H/C/002602
Active substance

vismodegib

International non-proprietary name (INN) or common name

vismodegib

Therapeutic area Carcinoma, Basal Cell
Anatomical therapeutic chemical (ATC) code L01XX43
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.

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 Erivedge
Marketing-authorisation holder

Roche Registration Ltd

Revision7
Date of issue of marketing authorisation valid throughout the European Union12/07/2013

Contact address:

Roche Registration Ltd
6 Falcon Way
Shire Park
Welwyn
Garden City AL7 1TW
United Kingdom

Product information

Product information

14/06/2016  Erivedge -EMEA/H/C/002602 -IB/0028

Name Language First published Last updated
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - Product Information HR = Hrvatski 30/07/2013 12/07/2016

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
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016
Erivedge : EPAR - All Authorised presentations HR = Hrvatski 30/07/2013 12/07/2016

Name Language First published Last updated
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  
Erivedge : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 30/07/2013  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of advanced basal-cell carcinoma

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Erivedge : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 28/07/2014 12/07/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Erivedge : EPAR - Public assessment report HR = Hrvatski 30/07/2013  
CHMP summary of positive opinion for Erivedge HR = Hrvatski 26/04/2013  

Authorised

This medicine is approved for use in the European Union