Lenvima

lenvatinib

  • Email
  • Help

About

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

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

What is Lenvima and what is it used for?

Lenvima is a cancer medicine used to treat adult patients with differentiated thyroid carcinoma, a type of cancer originating from the follicular cells of the thyroid gland. Lenvima is used when the cancer has progressed or spread locally or to other parts of the body, and does not respond to treatment with radioactive iodine.

Lenvima contains the active substance lenvatinib. Because the number of patients with differentiated thyroid carcinoma is low, the disease is considered ‘rare’, and Lenvima was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 26 April 2013.

How is Lenvima used?

Lenvima 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 medicine is available as capsules (4 mg and 10 mg). The recommended dose is 24 mg taken once a day at approximately the same time every day. The treatment is continued as long as the patient continues to benefit from it without too many side effects. To manage side effects, the doctor may decide to reduce the dose or stop treatment temporarily. In certain cases treatment should be permanently stopped. For further information, see the summary of product characteristics (also part of the EPAR).

How does Lenvima work?

The active substance in Lenvima, lenvatinib, is a ‘tyrosine-kinase inhibitor’. This means that it blocks the activity of enzymes known as tyrosine kinases. These enzymes can be found in certain receptors (such as VEGF, FGFR and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels. By blocking these enzymes, lenvatinib can block the formation of new blood vessels and hence cut off the blood supply that keeps cancer cells growing, and reduce their growth.

What benefits of Lenvima have been shown in studies?

Lenvima has been shown to be more effective than placebo (a dummy treatment) at slowing down disease progression in one main study. The study involved 392 adult patients with differentiated thyroid carcinoma that had shown signs of progression in the previous year and did not respond to treatment with radioactive iodine. The main measure of effectiveness was how long the patients lived without their disease getting worse: in the patients taking Lenvima this was an average of 18.3 months, compared with 3.6 months in those taking placebo.

What are the risks associated with Lenvima?

The most common side effects with Lenvima (which may affect more than 3 in 10 people) are hypertension (high blood pressure), diarrhoea, decreased appetite and weight, fatigue (tiredness), nausea (feeling sick), proteinuria (protein in the urine), stomatitis (inflammation of the lining of the mouth), vomiting, dysphonia (speech disturbances), headache and palmar-plantar erythrodysaesthesia syndrome (PPE - rash and numbness on the palms and soles). The most important serious side effects are kidney failure and impairment; problems with the heart and circulation such as heart failure, blood clots in the arteries leading to stroke or heart attack; bleeding into a tumour in the brain; a syndrome known as ‘posterior reversible encephalopathy syndrome’ characterised by headache, confusion, fits and loss of vision; and liver failure. For the full list of all side effects reported with Lenvima, see the package leaflet.

Lenvima must not be taken by breastfeeding women. For the full list of restrictions, see the package leaflet.

Why is Lenvima approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Lenvima’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that the medicine showed a clinically relevant improvement in the time patients lived without their disease getting worse. Regarding safety, the CHMP considered that the majority of adverse effects with Lenvima can be adequately managed by reducing the dose or temporarily interrupting treatment.

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

A risk management plan has been developed to ensure that Lenvima 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 Lenvima, 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 Lenvima

The European Commission granted a marketing authorisation valid throughout the European Union for Lenvima on 28 May 2015.

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

Name Language First published Last updated
Lenvima : EPAR - Summary for the public BG = bălgarski 25/06/2015  
Lenvima : EPAR - Summary for the public ES = español 25/06/2015  
Lenvima : EPAR - Summary for the public CS = čeština 25/06/2015  
Lenvima : EPAR - Summary for the public DA = dansk 25/06/2015  
Lenvima : EPAR - Summary for the public DE = Deutsch 25/06/2015  
Lenvima : EPAR - Summary for the public ET = eesti keel 25/06/2015  
Lenvima : EPAR - Summary for the public EL = elliniká 25/06/2015  
Lenvima : EPAR - Summary for the public EN = English 25/06/2015  
Lenvima : EPAR - Summary for the public FR = français 25/06/2015  
Lenvima : EPAR - Summary for the public IT = italiano 25/06/2015  
Lenvima : EPAR - Summary for the public LV = latviešu valoda 25/06/2015  
Lenvima : EPAR - Summary for the public LT = lietuvių kalba 25/06/2015  
Lenvima : EPAR - Summary for the public HU = magyar 25/06/2015  
Lenvima : EPAR - Summary for the public MT = Malti 25/06/2015  
Lenvima : EPAR - Summary for the public NL = Nederlands 25/06/2015  
Lenvima : EPAR - Summary for the public PL = polski 25/06/2015  
Lenvima : EPAR - Summary for the public PT = português 25/06/2015  
Lenvima : EPAR - Summary for the public RO = română 25/06/2015  
Lenvima : EPAR - Summary for the public SK = slovenčina 25/06/2015  
Lenvima : EPAR - Summary for the public SL = slovenščina 25/06/2015  
Lenvima : EPAR - Summary for the public FI = suomi 25/06/2015  
Lenvima : EPAR - Summary for the public SV = svenska 25/06/2015  
Lenvima : EPAR - Summary for the public HR = Hrvatski 25/06/2015  
Name Language First published Last updated
Lenvima : EPAR - Risk-management-plan summary (English only) 25/06/2015  

This EPAR was last updated on 25/06/2015 .

Authorisation details

Product details

Product details for Lenvima
NameLenvima
Agency product numberEMEA/H/C/003727
Active substance

lenvatinib mesylate

International non-proprietary name (INN) or common name

lenvatinib

Therapeutic area Thyroid Neoplasms
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.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Lenvima
Marketing-authorisation holder

Eisai Europe Ltd

Revision0
Date of issue of marketing authorisation valid throughout the European Union28/05/2015

Contact address:

Eisai Europe Ltd
European Knowledge Centre
Mosquito Way
Hertfordshire
Hatfield AL10 9SN
United Kingdom

Product information

Product information

28/05/2015  Lenvima -EMEA/H/C/003727 --

Name Language First published Last updated
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  
Lenvima : EPAR - Product Information EN = English 25/06/2015  

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
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  
Lenvima : EPAR - All Authorised presentations EN = English 25/06/2015  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Lenvima is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
CHMP summary of positive opinion for Lenvima EN = English 27/03/2015  

Initial marketing-authorisation documents

Name Language First published Last updated
Lenvima : EPAR - Public assessment report EN = English 25/06/2015