Iressa

gefitinib

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Iressa?

Iressa is a medicine that contains the active substance gefitinib. It is available as brown tablets (250 mg).

What is Iressa used for?

Iressa is used to treat adults who have non-small-cell lung cancer that is locally advanced or metastatic (when cancer cells have spread from the original site to other parts of the body). It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal-growth-factor receptor (EGFR).

How is Iressa used?

Treatment with Iressa should be started and supervised by a doctor who has experience with anticancer treatments. The recommended dose is one tablet once a day. The tablet can be dispersed in water for patients who have difficulty swallowing.

How does Iressa work?

The active substance in Iressa, gefitinib, is a protein-tyrosine-kinase inhibitor. This means that it blocks specific enzymes known as tyrosine kinases. These enzymes can be found on the surface of cancer cells, such as EGFR on the surface of non-small-cell-lung-cancer cells. EGFR is involved in the growth and spread of cancer cells. By blocking EGFR, Iressa helps to slow down the growth and spread of the cancer. Iressa works only in non-small-cell-lung-cancer cells that have a mutation in their EGFR.

How has Iressa been studied?

The effects of Iressa were first tested in experimental models before being studied in humans. In one main study involving 1,217 adult patients with locally advanced or metastatic non-small-cell lung cancer, Iressa was compared with a combination of carboplatin and paclitaxel (other anticancer medicines). The main measure of effectiveness was how long the patients lived without the disease getting worse.

In a second main study involving 1,466 patients with locally advanced or metastatic non-small-cell lung cancer, Iressa was compared with docetaxel (another anticancer medicine). The main measure of effectiveness was survival (how long the patients lived). Both studies included patients with and without the EGFR mutation.

What benefit has Iressa shown during the studies?

In the first main study, Iressa was more effective at preventing the cancer from worsening than the combination. Among patients with the EGFR mutation, those who took Iressa lived for an average of nine and a half months without the disease getting worse, compared with about six months for those who took the combination therapy. In the second main study, patient survival among all patients who took Iressa was similar to those who took docetaxel.

What is the risk associated with Iressa?

The most common side effects with Iressa (seen in more than 1 patient in 10) are loss of appetite, diarrhoea, vomiting, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), increased level of alanine aminotransferase (a liver enzyme) in the blood, skin reactions such as pustular rash, and asthenia (weakness). There is also a risk of interstitial lung disease in patients taking Iressa. For the full list of all side effects reported with Iressa, see the package leaflet.

Iressa should not be used in people who may be hypersensitive (allergic) to gefitinib or any of the other ingredients. It must not be used in mothers who are breastfeeding.

Why has Iressa been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Iressa’s benefits are greater than its risks for the treatment of adults with locally advanced or metastatic non-small-cell lung cancer with activating mutations of EGFR. The Committee recommended that Iressa be given marketing authorisation.

Other information about Iressa

The European Commission granted a marketing authorisation valid throughout the European Union for Iressa to AstraZeneca AB on 24 June 2009.

Name Language First published Last updated
Iressa : EPAR - Summary for the public BG = bălgarski 2009-07-22  
Iressa : EPAR - Summary for the public ES = español 2009-07-22  
Iressa : EPAR - Summary for the public CS = čeština 2009-07-22  
Iressa : EPAR - Summary for the public DA = dansk 2009-07-22  
Iressa : EPAR - Summary for the public DE = Deutsch 2009-07-22  
Iressa : EPAR - Summary for the public ET = eesti keel 2009-07-22  
Iressa : EPAR - Summary for the public EL = elliniká 2009-07-22  
Iressa : EPAR - Summary for the public EN = English 2009-07-22  
Iressa : EPAR - Summary for the public FR = français 2009-07-22  
Iressa : EPAR - Summary for the public IT = italiano 2009-07-22  
Iressa : EPAR - Summary for the public LV = latviešu valoda 2009-07-22  
Iressa : EPAR - Summary for the public LT = lietuvių kalba 2009-07-22  
Iressa : EPAR - Summary for the public HU = magyar 2009-07-22  
Iressa : EPAR - Summary for the public MT = Malti 2009-07-22  
Iressa : EPAR - Summary for the public NL = Nederlands 2009-07-22  
Iressa : EPAR - Summary for the public PL = polski 2009-07-22  
Iressa : EPAR - Summary for the public PT = português 2009-07-22  
Iressa : EPAR - Summary for the public RO = română 2009-07-22  
Iressa : EPAR - Summary for the public SK = slovenčina 2009-07-22  
Iressa : EPAR - Summary for the public SL = slovenščina 2009-07-22  
Iressa : EPAR - Summary for the public FI = suomi 2009-07-22  
Iressa : EPAR - Summary for the public SV = svenska 2009-07-22  

This EPAR was last updated on 13/10/2016 .

Authorisation details

Product details

Product details for Iressa
NameIressa
Agency product numberEMEA/H/C/001016
Active substance

gefitinib

International non-proprietary name (INN) or common name

gefitinib

Therapeutic area Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code L01XE02

Publication details

Publication details for Iressa
Marketing-authorisation holder

AstraZeneca AB

Revision9
Date of issue of marketing authorisation valid throughout the European Union24/06/2009

Contact address:

AstraZeneca AB
151 85 Södertälje
Sweden

Product information

Product information

15/09/2016  Iressa -EMEA/H/C/001016 -II/0024

Name Language First published Last updated
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13
Iressa : EPAR - Product Information SV = svenska 2009-07-22 2016-10-13

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
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01
Iressa : EPAR - All Authorised presentations SV = svenska 2009-07-22 2010-02-01

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase (see section 5.1).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Iressa : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2010-02-01 2016-10-13

Initial marketing-authorisation documents

Name Language First published Last updated
Iressa : EPAR - Public assessment report SV = svenska 2009-07-22  
Committee for medicinal products for human use, summary of positive opinion for Iressa SV = svenska 2009-04-23  

Authorised

This medicine is approved for use in the European Union