Alecensa

alectinib

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

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

What is Alecensa and what is it used for?

Alecensa 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 used on its own and only 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).

Alecensa contains the active substance alectinib.

How is Alecensa used?

Alecensa 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 4 capsules (600 mg) taken twice a day with food. 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 Alecensa 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 Alecensa, alectinib, is an ALK inhibitor and works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer.

What benefits of Alecensa have been shown in studies?

Alecensa has been investigated in two main studies involving 225 patients in whom the disease progressed despite previous treatment with crizotinib (Xalkori). In both studies, which were still ongoing at the time of Alecensa evaluation, the medicine was not compared with any other treatment or placebo (a dummy treatment). Response to treatment was assessed using body scans and standardised criteria for solid tumours, with complete response being when the patient had no remaining signs of the cancer.

In one study around 52% of patients given Alecensa (35 out of 67) were considered by the treating doctors to have shown a complete or partial response to the medicine at the time of analysis. In the second study, the complete or partial response rate at the time of analysis was 51% (62 out of 122 patients). The average length of response was 14.9 months in the first study, and 15.2 months in the second study.

What are the risks associated with Alecensa?

The most common side effects with Alecensa (which may affect more than 2 in 10 people) are constipation, oedema (swelling, including of the ankles and feet and of the eyelids and area around the eyes), muscle pain and nausea (feeling sick). The most common severe reactions (which may affect 1 or more people in 100) were abnormal liver tests, anaemia (low levels of red blood cells), increases in the blood level of creatine phosphokinase (an enzyme in muscles which can be raised in the blood when muscles are damaged) and diarrhoea.

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

Why is Alecensa approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Alecensa’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 Xalkori currently have very limited treatment options and therefore a high unmet clinical need. The currently available evidence was sufficient to show that Alecensa could be of benefit in these patients, although further data to confirm this are awaited. The safety profile of Alecensa was considered acceptable and in line with that of other ALK inhibitors.

Alecensa 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 Alecensa?

Since Alecensa has been granted a conditional approval, the company that markets Alecensa will provide results of a further study comparing Alecensa with Xalkori in patients with ALK-positive NSCLC who did not receive previous treatment.

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

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

Other information about Alecensa

The European Commission granted a marketing authorisation valid throughout the European Union for Alecensa on 16/02/2017. 

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

Name Language First published Last updated
Alecensa : EPAR - Summary for the public BG = bălgarski 2017-04-11  
Alecensa : EPAR - Summary for the public ES = español 2017-04-11  
Alecensa : EPAR - Summary for the public CS = čeština 2017-04-11  
Alecensa : EPAR - Summary for the public DA = dansk 2017-04-11  
Alecensa : EPAR - Summary for the public DE = Deutsch 2017-04-11  
Alecensa : EPAR - Summary for the public ET = eesti keel 2017-04-11  
Alecensa : EPAR - Summary for the public EL = elliniká 2017-04-11  
Alecensa : EPAR - Summary for the public EN = English 2017-04-11  
Alecensa : EPAR - Summary for the public FR = français 2017-04-11  
Alecensa : EPAR - Summary for the public IT = italiano 2017-04-11  
Alecensa : EPAR - Summary for the public LV = latviešu valoda 2017-04-11  
Alecensa : EPAR - Summary for the public LT = lietuvių kalba 2017-04-11  
Alecensa : EPAR - Summary for the public HU = magyar 2017-04-11  
Alecensa : EPAR - Summary for the public MT = Malti 2017-04-11  
Alecensa : EPAR - Summary for the public NL = Nederlands 2017-04-11  
Alecensa : EPAR - Summary for the public PL = polski 2017-04-11  
Alecensa : EPAR - Summary for the public PT = português 2017-04-11  
Alecensa : EPAR - Summary for the public RO = română 2017-04-11  
Alecensa : EPAR - Summary for the public SK = slovenčina 2017-04-11  
Alecensa : EPAR - Summary for the public SL = slovenščina 2017-04-11  
Alecensa : EPAR - Summary for the public FI = suomi 2017-04-11  
Alecensa : EPAR - Summary for the public SV = svenska 2017-04-11  
Alecensa : EPAR - Summary for the public HR = Hrvatski 2017-04-11  

This EPAR was last updated on 16/05/2017 .

Authorisation details

Product details

Product details for Alecensa
NameAlecensa
Agency product numberEMEA/H/C/004164
Active substance

alectinib hydrochloride

International non-proprietary name (INN) or common name

alectinib

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 Alecensa
Marketing-authorisation holder

Roche Registration Limited

Revision1
Date of issue of marketing authorisation valid throughout the European Union16/02/2017

Contact address:

Roche Registration Limited
6 Falcon Way 
Shire Park 
Welwyn Garden City 
AL7 1TW 
United Kingdom

Product information

Product information

18/04/2017  Alecensa -EMEA/H/C/004164 -IB/0002

Name Language First published Last updated
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16
Alecensa : EPAR - Product Information HR = Hrvatski 2017-04-11 2017-05-16

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
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  
Alecensa : EPAR - All Authorised presentations HR = Hrvatski 2017-04-11  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Alecensa as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Alecensa : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-05-16  

Initial marketing-authorisation documents

Name Language First published Last updated
Alecensa : EPAR - Public assessment report HR = Hrvatski 2017-04-11  
CHMP summary of positive opinion for Alecensa HR = Hrvatski 2016-12-16  

Authorised

This medicine is approved for use in the European Union