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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/218681/2015

EMEA/H/C/003727

EPAR summary for the public

Lenvima

lenvatinib

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

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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

Lenvima

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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.

The full EPAR and risk management plan summary for Lenvima can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Lenvima, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The summaries of the opinion of the Committee for Orphan Medicinal Products for Lenvima can be found on the Agency's website:

Follicular thyroid cancer: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. Papillary thyroid cancer: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.

This summary was last updated in 05-2015.

Lenvima

EMA/218681/2015