Xalkori

crizotinib

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This is a summary of the European public assessment report (EPAR) for Xalkori. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xalkori.

What is Xalkori?

Xalkori is a medicine that contains the active substance crizotinib. It is available as capsules (200 mg and 250 mg).

What is Xalkori used for?

Xalkori is used to treat adults with a type of lung cancer called non-small-cell lung cancer (NSCLC), when the disease is advanced and has already been treated before. It is only used if the NSCLC is ‘ALK-positive’, which means that the cancer cells contain certain defects affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).

The medicine can only be obtained with a prescription.

How is Xalkori used?

Treatment with Xalkori should be started and supervised by a doctor who is experienced in using anticancer medicines. The presence of the genetic defect affecting ALK (‘ALK-positive’ status) has to be confirmed in advance by appropriate methods.

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. In certain cases treatment should be permanently stopped, including if the patient has a severely prolonged QT interval (an alteration of the electrical activity of the heart). The dose may need to be adjusted in patients with severe kidney problems and the medicine should not be used in patients with severe liver problems.

For further information, see the package leaflet.

How does Xalkori work?

ALK belongs to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth and spread of certain cancers 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, including when the genetic defect is present, thereby reducing the growth and spread of the cancer in ALK-positive NSCLC.

How has Xalkori been studied?

Xalkori was investigated in two main studies involving 386 patients with ALK-positive NSCLC who had been treated before. Xalkori was not compared with any other treatment. In both studies, the main measure of effectiveness was the percentage of patients who responded completely or partially to treatment. Response to treatment was assessed using body scans and standardised criteria used for solid tumours. A complete response is when a patient has no signs of the cancer. Other factors were also taken into consideration, including the length of time the patients lived without the disease getting worse.

What benefit has Xalkori shown during the studies?

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.

What is the risk associated with Xalkori?

The most common side effects with Xalkori (seen in more than 1 in 5 patients) are vision problems, nausea (feeling sick), diarrhoea, vomiting, oedema (swelling), increases in liver enzymes in the blood, constipation and fatigue. For the full list of all side effects reported with Xalkori, see the package leaflet. The most serious side effects are liver toxicity, pneumonitis (lung inflammation), neutropenia (low levels of neutrophils, a type of white blood cell) and prolonged QT interval.

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

Why has Xalkori been approved?

The CHMP concluded that the available study results showed that treatment with Xalkori has a beneficial effect, and noted that this was supported by updated data on the survival of patients and the preliminary results of a larger study. Therefore the CHMP decided that Xalkori’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Xalkori has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, in particular data from a larger study and the longer term outcomes of patients included in the studies already considered. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Xalkori?

The company that markets Xalkori will provide the final results of a study in patients with ALK-positive NSCLC comparing the safety and effectiveness of Xalkori with chemotherapy treatments, to confirm how long patients lived overall. Additional safety data from this study will also be provided.

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

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

In addition, the company that markets Xalkori will ensure that doctors who are expected to prescribe Xalkori receive educational material containing important safety information about the medicine, including the risk of QT prolongation, and a patient alert card.

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 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public ES = español 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public CS = čeština 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public DA = dansk 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public DE = Deutsch 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public ET = eesti keel 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public EL = elliniká 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public EN = English 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public FR = français 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public IT = italiano 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public LV = latviešu valoda 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public LT = lietuvių kalba 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public HU = magyar 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public MT = Malti 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public NL = Nederlands 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public PL = polski 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public PT = português 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public RO = română 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public SK = slovenčina 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public SL = slovenščina 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public FI = suomi 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public SV = svenska 14/11/2012 07/05/2014
Xalkori : EPAR - Summary for the public HR = Hrvatski 14/11/2012 07/05/2014

This EPAR was last updated on 16/06/2014 .

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.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Xalkori
Marketing-authorisation holder

Pfizer Ltd.  

Revision6
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

14/05/2014  Xalkori -EMEA/H/C/002489 -PSUV/12

Name Language First published Last updated
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014
Xalkori : EPAR - Product Information HR = Hrvatski 14/11/2012 16/06/2014

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

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Xalkori : EPAR - Public assessment report HR = Hrvatski 14/11/2012  
CHMP summary of positive opinion for Xalkori HR = Hrvatski 20/07/2012  

Authorised

This medicine is approved for use in the European Union