Xalkori

crizotinib

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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.

What is Xalkori and what is it used for?

Xalkori is a medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the disease is advanced:

  • It is used if the NSCLC is ‘ALK-positive’, which means that the cancer cells contain certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).
  • It is also used when the NSCLC is ‘ROS1-positive’. This means that the cancer cells contain changes affecting the gene responsible for the protein ROS1.

Xalkori contains the active substance crizotinib.

How is Xalkori used?

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 in advance by appropriate methods.

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.

How does Xalkori work?

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.

What benefits of Xalkori have been shown in studies?

ALK-positive NSCLC

A study in 347 previously treated ALK-positivepatients 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 around 70% of patients taking Xalkori (37 out of 53) responding 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.

What is the risk 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 fatigue. The most serious side effects are liver toxicity, 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). For the full list of all side effects reported with Xalkori, see the package leaflet.

Xalkori must not be used in patients with severely reduced liver function. For the full list of restrictions, see the package leaflet.

Why is Xalkori approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that treatment with Xalkori has a beneficial effect on the length of time the patients with ALK-positive NSCLC lived without the disease getting worse, irrespective of whether they were previously treated. For patients with ROS1-positive NSCLC, for whom no specific treatments are currently available, the CHMP noted the evidence of a high response rate, in particular for patients who had previously received other cancer treatments. Therefore the CHMP decided that Xalkori’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

In the studies with previously treated patients, Xalkori was shown to be effective in treating ALK-positive NSCLC, with 60% of the patients in the first study and 53% in the second study responding completely or partially to treatment. The length of time the patients lived without the disease getting worse in the two studies was 9.2 and 8.5 months respectively.

In the study in previously untreated patients, those 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.

Other information about Xalkori

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.

Name Language First published Last updated
Xalkori : EPAR - Summary for the public BG = bălgarski 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public ES = español 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public CS = čeština 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public DA = dansk 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public DE = Deutsch 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public ET = eesti keel 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public EL = elliniká 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public EN = English 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public FR = français 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public IT = italiano 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public LV = latviešu valoda 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public LT = lietuvių kalba 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public HU = magyar 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public MT = Malti 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public NL = Nederlands 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public PL = polski 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public PT = português 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public RO = română 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public SK = slovenčina 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public SL = slovenščina 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public FI = suomi 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public SV = svenska 2012-11-14 2017-10-23
Xalkori : EPAR - Summary for the public HR = Hrvatski 2012-11-14 2017-10-23

This EPAR was last updated on 23/10/2017 .

Authorisation details

Product details

Product details for Xalkori
NameXalkori
Agency product numberEMEA/H/C/002489
Active substance

crizotinib

International non-proprietary name (INN) or common name

crizotinib

Therapeutic area Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code L01XE16
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 Xalkori
Marketing-authorisation holder

Pfizer Ltd

Revision18
Date of issue of marketing authorisation valid throughout the European Union23/10/2012

Contact address:

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Product information

Product information

06/07/2017  Xalkori -EMEA/H/C/002489 -II/0049/G

Name Language First published Last updated
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22
Xalkori : EPAR - Product Information HR = Hrvatski 2012-11-14 2017-08-22

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
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  
Xalkori : EPAR - All Authorised presentations HR = Hrvatski 2012-11-14  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Xalkori is indicated for the first-line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC).

Xalkori is indicated for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC).

Assessment History