Zykadia

ceritinib

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

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

What is Zykadia and what is it used for?

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

Zykadia contains the active substance ceritinib.

How is Zykadia used?

Zykadia can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines. The presence of genetic defects affecting ALK (‘ALK-positive’ status) has to be confirmed in advance by appropriate methods.

The medicine is available as capsules (150 mg). The recommended dose is 750 mg (5 capsules) once a day taken on an empty stomach and no food should be eaten for 2 hours before or after the dose. The doctor may decide to reduce the dose or stop treatment temporarily if side effects occur. In certain cases treatment should be permanently stopped. For further information see the summary of product characteristics (also part of the EPAR).

How does Zykadia work?

ALK belongs to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them. In patients with ALK-positive NSCLC, an abnormal form of ALK is produced that stimulates the cancer cells to divide and grow in an uncontrolled fashion. The active substance in Zykadia, ceritinib, works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer.

What benefits of Zykadia have been shown in studies?

Zykadia has been investigated in two main studies involving 303 patients in whom the disease progressed despite previous treatment with crizotinib (Xalkori). In both studies, which were still ongoing at the time of Zykadia’s evaluation, the medicine was not compared with any other treatment. Response to treatment was assessed using body scans and standardised criteria used for solid tumours, with complete response being when the patient had no remaining signs of the cancer. In one study 56% of patients given Zykadia (92 of 163) were considered by the treating doctors to have shown a complete or partial response to the medicine at the time of analysis. The average length of response was 8.3 months. In the second study, the overall response rate at the time of analysis was 37% (52 of 140 patients) and the average length of response was 9.2 months.

Results were also presented in patients who had not been previously treated with crizotinib or similar medicines. However, the evidence was insufficient to support the use of Zykadia in these patients.

What are the risks associated with Zykadia?

The most common side effects with Zykadia (which may affect 1 or more people in 10) are diarrhoea, nausea (feeling sick), vomiting, tiredness, abnormal liver tests, abdominal pain (stomach ache), decreased appetite, constipation, rash, increases in the level of a waste product called creatinine in the blood (a possible sign of kidney problems), oesophageal disorder (problems affecting the gullet between mouth and stomach) and anaemia (low levels of red blood cells). The most common severe reactions (which may affect 1 or more people in 20) were abnormal liver tests, tiredness, diarrhoea, nausea, and hyperglycaemia (high blood sugar).

For the full list of all side effects and restrictions with Zykadia, see the package leaflet.

Why is Zykadia approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Zykadia’s benefits are greater than its risks and recommended that it be approved for use in the EU. Patients whose disease progresses during or shortly after treatment with crizotinib currently have very limited treatment options and therefore a high unmet clinical need. The currently available evidence was sufficient to show that Zykadia could be of benefit in these circumstances, although further data to confirm this are awaited. Regarding safety, the adverse effects with Zykadia generally appeared manageable.

Zykadia has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Zykadia?

Since Zykadia has been granted a conditional approval, the company that markets Zykadia will provide final results from the ongoing second study used to approve licensing, as well as the results of a further study comparing Zykadia with other cancer medicines (chemotherapy) in patients with ALK-positive NSCLC previously treated with crizotinib.

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

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

Further information can be found in the summary of the risk management plan.

Other information about Zykadia

The European Commission granted a marketing authorisation valid throughout the European Union for Zykadia on 06 May 2015

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

Name Language First published Last updated
Zykadia : EPAR - Summary for the public BG = bălgarski 04/06/2015  
Zykadia : EPAR - Summary for the public ES = español 04/06/2015  
Zykadia : EPAR - Summary for the public CS = čeština 04/06/2015  
Zykadia : EPAR - Summary for the public DA = dansk 04/06/2015  
Zykadia : EPAR - Summary for the public DE = Deutsch 04/06/2015  
Zykadia : EPAR - Summary for the public ET = eesti keel 04/06/2015  
Zykadia : EPAR - Summary for the public EL = elliniká 04/06/2015  
Zykadia : EPAR - Summary for the public EN = English 04/06/2015  
Zykadia : EPAR - Summary for the public FR = français 04/06/2015  
Zykadia : EPAR - Summary for the public IT = italiano 04/06/2015  
Zykadia : EPAR - Summary for the public LV = latviešu valoda 04/06/2015  
Zykadia : EPAR - Summary for the public LT = lietuvių kalba 04/06/2015  
Zykadia : EPAR - Summary for the public HU = magyar 04/06/2015  
Zykadia : EPAR - Summary for the public MT = Malti 04/06/2015  
Zykadia : EPAR - Summary for the public NL = Nederlands 04/06/2015  
Zykadia : EPAR - Summary for the public PL = polski 04/06/2015  
Zykadia : EPAR - Summary for the public PT = português 04/06/2015  
Zykadia : EPAR - Summary for the public RO = română 04/06/2015  
Zykadia : EPAR - Summary for the public SK = slovenčina 04/06/2015  
Zykadia : EPAR - Summary for the public SL = slovenščina 04/06/2015  
Zykadia : EPAR - Summary for the public FI = suomi 04/06/2015  
Zykadia : EPAR - Summary for the public SV = svenska 04/06/2015  
Zykadia : EPAR - Summary for the public HR = Hrvatski 04/06/2015  
Name Language First published Last updated
Zykadia : EPAR - Risk-management-plan summary (English only) 04/06/2015  

This EPAR was last updated on 15/04/2016 .

Authorisation details

Product details

Product details for Zykadia
NameZykadia
Agency product numberEMEA/H/C/003819
Active substance

ceritinib

International non-proprietary name (INN) or common name

ceritinib

Therapeutic area Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code L01XE
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 Zykadia
Marketing-authorisation holder

Novartis Europharm Ltd

Revision3
Date of issue of marketing authorisation valid throughout the European Union06/05/2015

Contact address:

Novartis Europharm Ltd
Frimley Business Park
Camberley GU16 7SR
United Kingdom

Product information

Product information

22/03/2016  Zykadia -EMEA/H/C/003819 -R/0004

Name Language First published Last updated
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015
Zykadia : EPAR - Product Information EN = English 04/06/2015 28/09/2015

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
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015
Zykadia : EPAR - All Authorised presentations EN = English 04/06/2015 09/07/2015

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of anaplastic lymphomakinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Zykadia : EPAR - Procedural steps taken and scientific information after authorisation EN = English 09/07/2015 15/04/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Zykadia : EPAR - Public assessment report EN = English 04/06/2015  
CHMP summary of positive opinion for Zykadia EN = English 27/02/2015