Drug

IRESSA®

gefitinib

IRESSA Overview

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).

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.

The active substance in Keytruda, pembrolizumab, is a monoclonal antibody, a protein that has been designed to recognise and block a receptor (‘target’) called PD-1. Some cancers can make a protein (PD-L1) that combines with PD-1 to switch off the activity of certain cells of the immune system (the body’s natural defences) preventing them from attacking the cancer. By blocking PD-1, pembrolizumab stops the cancer switching off these immune cells, thereby increasing the immune system’s ability to kill the cancer cells.

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.

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.

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

What are the risks 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.

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.

Owner of copyright and other intellectual property rights to European Medicines Agency

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