Xalkori Overview

This is a summary of the European public assessment report (EPAR) for Xalkori. 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 Xalkori.

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

Treatment with Xalkori should be started and supervised by a doctor who is experienced in using cancer medicines. The presence of the genetic changes affecting ALK (‘ALK-positive’ status) or ROS1 (‘ROS1-positive’ status) has to be confirmed before starting treatment with Xalkori.

Xalkori is available as capsules (200 mg and 250 mg).The recommended dose is 250 mg twice per day. If certain side effects develop the doctor may decide to interrupt or reduce the dose to 200 mg twice per day then to 250 mg once per day. Doses may need to be delayed or treatment stopped altogether if the patient develops certain severe side effects. Doses may need to be adjusted in patients with severely reduced kidney function.

For further information, see the package leaflet. The medicine can only be obtained with a prescription.

ALK and ROS1 belong to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells. In patients either ‘ALK-positive’ or ‘ROS1-positive’, the ALK or ROS1 protein is abnormally active and can promote the growth of cancer cells and the development of new blood vessels that supply them.

The active substance in Xalkori, crizotinib, is an RTK inhibitor. It works mainly by blocking the activity of ALK or ROS1, including when the genetic change is present, thereby reducing the growth and spread of the cancer in ALK-positive or in ROS1-positive NSCLC.

ALK-positive NSCLC

A study in 347 previously treated ALK-positive patients showed that those taking Xalkori lived on average for nearly 8 months without their disease getting worse compared with 3 months in patients who were treated with either pemetrexed or docetaxel.

In another study in 343 patients who had not received previous treatment for their NSCLC before, patients treated with Xalkori lived on average for nearly 11 months without their disease getting worse compared with 7 months in patients who were treated with pemetrexed-containing therapy.

ROS1-positive NSCLC

A study in 53 ROS1-positive patients with advanced disease showed that around 70% of patients taking Xalkori (37 out of 53) responded completely or partially to treatment. This is considered a favourable response when compared with response rates of around 20 to 30% to previous treatments, in those patients who had been given them. For the previously untreated patients, 6 out of 7 responded to treatment.

The European Medicines Agency concluded that treatment with Xalkori increases the time patients with ALK-positive NSCLC live without the disease getting worse, irrespective of whether they are previously treated. For patients with ROS1-positive NSCLC, for whom no specific treatments are currently available, the Agency noted the evidence of a high response rate, in particular for patients who had previously received other cancer treatments. Therefore the Agency decided that Xalkori’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The company that markets Xalkori will ensure that doctors who are expected to prescribe Xalkori receive a pack containing the medicine’s summary of product characteristics and a patient alert card to be given to patients.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xalkori have also been included in the summary of product characteristics and the package leaflet.

The European Commission granted a marketing authorisation valid throughout the European Union for Xalkori on 23 October 2012.

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

What are the risks associated with Xalkori?

The most common side effects with Xalkori (seen in more than 1 in 4 patients) are vision problems, nausea (feeling sick), diarrhoea, vomiting, oedema (swelling), increases in liver enzymes in the blood, decreased appetite, constipation, dizziness, neuropathy (pain due to nerve damage) and tiredness. The most serious side effects are liver damage, pneumonitis (lung inflammation), neutropenia (low blood levels of neutrophils, a type of white blood cell) and prolonged QT interval (a problem with the electrical activity of the heart).

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

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