Inlyta

axitinib

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

What is Inlyta?

Inlyta is a medicine that contains the active substance axitinib. It is available as tablets (1, 3, 5 and 7 mg)

What is Inlyta used for?

Inlyta is used to treat adults with advanced renal-cell carcinoma, a type of kidney cancer. ‘Advanced’ means that the cancer has started to spread. Inlyta is used when treatment with Sutent (sunitinib) or ‘cytokines’ (other anticancer medicines) has failed.

The medicine can only be obtained with a prescription.

How is Inlyta used?

Treatment with Inlyta should be started by doctors who have experience in using anticancer medicines.

The recommended starting dose is 5 mg twice a day, taken approximately 12 hours apart. The dose can be adjusted according to the patient’s response. In patients who tolerate the 5-mg dose well, who do not have high blood pressure and are not taking blood-pressure medicines, the dose may be increased first to 7 mg then to a maximum of 10 mg twice a day. It may be necessary to reduce the dose or interrupt treatment to manage certain side effects. In patients taking certain other medicines, the doctor may need to adjust the dose of Inlyta.

Patients with moderately reduced liver function should receive a starting dose of 2 mg twice a day. Inlyta should not be used in patients with severely reduced liver function.

How does Inlyta work?

The active substance in Inlyta, axitinib, works by blocking some enzymes known as tyrosine kinases that are found in ‘vascular endothelial growth factor’ (VEGF) receptors on the surface of cancer cells. VEGF receptors are involved in the growth and spread of cancer cells and in the development of blood vessels that supply the tumours. By blocking these receptors, Inlyta helps to reduce the growth and spread of the cancer and cut off the blood supply that keeps the cancer cells growing.

How has Inlyta been studied?

Inlyta has been compared with sorafenib (another anticancer medicine) in one main study involving 723 patients with advanced renal-cell carcinoma whose previous treatment with other anticancer medicines such as sunitinib or cytokines had failed. The main measure of effectiveness was how long the patients lived without their tumour getting worse.

What benefit has Inlyta shown during the studies?

Inlyta was more effective than sorafenib in treating advanced renal-cell carcinoma. Patients taking Inlyta lived for an average of 6.7 months without the disease getting worse, compared with 4.7 months in the patients taking sorafenib. Effects were better for those patients who were previously treated with cytokines rather than sunitinib.

What is the risk associated with Inlyta?

The most important serious side effects with Inlyta are arterial or venous embolic and thrombotic events (blood clots in the arteries or veins), haemorrhage (bleeding), gastrointestinal perforation (hole in the gut) and fistula formation (abnormal passageways between the gut and other organs), hypertensive crisis (severe increase in blood pressure), and posterior reversible encephalopathy syndrome (reversible swelling in the brain).

The most common side effects with Inlyta (seen in more than 20% of patients) are diarrhoea, hypertension (high blood pressure), fatigue (tiredness), dysphonia (speech disturbance), nausea (feeling sick), decreased appetite and palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms of the hands and soles of the feet).

For the full list of all side effects reported with Inlyta, see the package leaflet.

Inlyta must not be used in people who are hypersensitive (allergic) to axitinib or any of the other ingredients.

Why has Inlyta been approved?

The CHMP concluded that the effectiveness of Inlyta in treating patients with advanced renal-cell carcinoma for whom treatment with Sutent or a cytokine failed has been demonstrated. Regarding its safety, the side effects of the medicine are similar to other medicines in the same class and are considered to be acceptable and manageable. The CHMP therefore decided that Inlyta’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Inlyta

The European Commission granted a marketing authorisation valid throughout the European Union for Inlyta on 3 September 2012.

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

Name Language First published Last updated
Inlyta : EPAR - Summary for the public BG = bălgarski 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public ES = español 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public CS = čeština 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public DA = dansk 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public DE = Deutsch 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public ET = eesti keel 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public EL = elliniká 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public EN = English 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public FR = français 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public IT = italiano 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public LV = latviešu valoda 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public LT = lietuvių kalba 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public HU = magyar 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public MT = Malti 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public NL = Nederlands 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public PL = polski 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public PT = português 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public RO = română 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public SK = slovenčina 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public SL = slovenščina 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public FI = suomi 13/09/2012 05/09/2013
Inlyta : EPAR - Summary for the public SV = svenska 13/09/2012 05/09/2013

This EPAR was last updated on 17/12/2013 .

Authorisation details

Product details

Product details for Inlyta
NameInlyta
Agency product numberEMEA/H/C/002406
Active substance

axitinib

International non-proprietary name (INN) or common name

axitinib

Therapeutic area Carcinoma, Renal Cell
Anatomical therapeutic chemical (ATC) code L01XE17
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 Inlyta
Marketing-authorisation holder

Pfizer Ltd.
 

Revision3
Date of issue of marketing authorisation valid throughout the European Union03/09/2012

Contact address:

Pfizer Ltd.
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

Product information

24/10/2013  Inlyta -EMEA/H/C/002406 -II/0003

Name Language First published Last updated
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013
Inlyta : EPAR - Product Information SV = svenska 13/09/2012 17/12/2013

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
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013
Inlyta : EPAR - All Authorised presentations SV = svenska 13/09/2012 05/09/2013

Pharmacotherapeutic group

Protein-kinase inhibitors

Therapeutic indication

Inlyta is indicated for the treatment of adult patients with advanced renal-cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Inlyta : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 18/07/2013 17/12/2013

Initial marketing-authorisation documents

Name Language First published Last updated
Inlyta : EPAR - Public assessment report SV = svenska 13/09/2012  
CHMP summary of positive opinion for Inlyta SV = svenska 25/05/2012  

Authorised

This medicine is approved for use in the European Union