Stivarga

regorafenib

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This is a summary of the European public assessment report (EPAR) for Stivarga. It explains how the European Medicines 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 Stivarga.

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

What is Stivarga and what is it used for?

Stivarga is an anticancer medicine that contains the active substance regorafenib. It is used to treat the following cancers:

  • colorectal cancer (cancer of the bowel and rectum) that has spread to other parts of the body;
  • gastrointestinal stromal tumour (GIST -, a cancer of the stomach and bowel) that has spread and cannot be surgically removed.

Stivarga is used in patients who have already been treated with, or who cannot be given, other available treatments. For colorectal cancer these include chemotherapy based on medicines called fluoropyrimidines and treatment with other cancer medicines known as anti‑VEGF and anti‑EGFR therapies. Patients with GIST will have tried treatment with imatinib and sunitinib.

How is Stivarga used?

Treatment with Stivarga must be prescribed by a doctor who is experienced in treating cancer. The medicine can only be obtained with a prescription.

Stivarga is available as tablets (40 mg). It is taken in 4-week treatment cycles at a recommended starting dose of 160 mg once every day for three weeks, followed by a week off. Doses should be taken at the same time each day with a light meal. Treatment should continue for as long as possible, until the disease worsens or the side effects become too severe. Treatment may need to be interrupted or stopped, or the dose reduced, if the patient experiences certain side effects. For further information, see the summary of product characteristics (also part of the EPAR).

How does Stivarga work?

The active substance in Stivarga, regorafenib, is a ‘protein-kinase inhibitor’. This means that it blocks several enzymes that are important for the development of a blood supply to tumours and the growth and development of cancer cells. By blocking the action of these enzymes, Stivarga helps to restrict the growth and spread of the cancer.

What benefits of Stivarga have been shown in studies?

In a main study involving 760 patients with metastatic colorectal cancer which had progressed after standard therapy, Stivarga was compared with placebo (a dummy treatment) and the main measure of effectiveness was overall survival (the length of time that patients lived). All patients also received supportive care, including pain medicines and treatment for infections and low blood-cell counts. The study showed that Stivarga improved survival, with treated patients living for 196 days on average, compared with 151 days for those given placebo.

In another main study Stivarga was compared with placebo in 199 patients with GIST that had spread or was inoperable and who were also given best supportive care. Supportive care included treatments like pain relief, antibiotics, and blood transfusions that help the patient but without treating the cancer. The study showed that Stivarga with supportive care was effective at prolonging the length of time patients lived without their disease getting worse. Patients treated with Stivarga lived on average for 147 days without their disease getting worse compared with 28 days for patients taking placebo and supportive care.

What are the risks associated with Stivarga?

The most common side effects with Stivarga (which may affect more than 3 in 10 people) are weakness, tiredness, loss of appetite and eating less, hand-foot syndrome (rash and numbness affecting the palms and soles), diarrhoea, infection, hypertension (high blood pressure) and dysphonia (voice changes). The most serious side effects are severe liver injury, bleeding and gastrointestinal perforation (development of a hole in the wall of the gut).

For the full list of all side effects reported with Stivarga, see the package leaflet.

Why is Stivarga approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Stivarga’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee noted that in colorectal cancer the benefits in terms of extending patient survival were modest, but considered that they outweighed the risks in patients for whom there are no other remaining treatment options. However, given the side effects, the CHMP considered it important to find ways to identify any subgroups of patients who are more likely to respond to Stivarga.

With regard to GIST, the Committee noted that the outlook is poor for patients whose disease gets worse despite treatment with imatinib and sunitinib. Stivarga had been shown to delay the worsening of the disease in these patients and its side effects are manageable.

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

A risk management plan has been developed to ensure that Stivarga 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 Stivarga, including the appropriate precautions to be followed by healthcare professionals and patients.

The company that markets Stivarga will also carry out studies to look for ways of identifying patients who are more likely to respond to treatment.

Other information about Stivarga

The European Commission granted a marketing authorisation valid throughout the European Union for Stivarga on 26 August 2013.

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

Name Language First published Last updated
Stivarga : EPAR - Summary for the public BG = bălgarski 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public ES = español 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public CS = čeština 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public DA = dansk 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public DE = Deutsch 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public ET = eesti keel 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public EL = elliniká 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public EN = English 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public FR = français 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public IT = italiano 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public LV = latviešu valoda 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public LT = lietuvių kalba 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public HU = magyar 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public MT = Malti 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public NL = Nederlands 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public PL = polski 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public PT = português 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public RO = română 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public SK = slovenčina 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public SL = slovenščina 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public FI = suomi 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public SV = svenska 12/09/2013 18/09/2014
Stivarga : EPAR - Summary for the public HR = Hrvatski 12/09/2013 18/09/2014

This EPAR was last updated on 29/04/2016 .

Authorisation details

Product details

Product details for Stivarga
NameStivarga
Agency product numberEMEA/H/C/002573
Active substance

regorafenib

International non-proprietary name (INN) or common name

regorafenib

Therapeutic area Colorectal Neoplasms
Anatomical therapeutic chemical (ATC) code L01XE21
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.

Publication details

Publication details for Stivarga
Marketing-authorisation holder

Bayer Pharma AG

Revision6
Date of issue of marketing authorisation valid throughout the European Union26/08/2013

Contact address:

Bayer Pharma AG
13342 Berlin 
Germany

Product information

Product information

17/03/2016  Stivarga -EMEA/H/C/002573 -II/0006

Name Language First published Last updated
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016
Stivarga : EPAR - Product Information HR = Hrvatski 12/09/2013 29/04/2016

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
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  
Stivarga : EPAR - All Authorised presentations HR = Hrvatski 12/09/2013  

Pharmacotherapeutic group

Antineoplastic agents, protein-kinase inhibitors

Therapeutic indication

Stivarga is indicated for the treatment of adult patients with:

  • metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies - these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy;
  • unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Stivarga : EPAR - Public assessment report HR = Hrvatski 12/09/2013  
CHMP summary of positive opinion for Stivarga HR = Hrvatski 28/06/2013  

Authorised

This medicine is approved for use in the European Union