Lenvima

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).

For treatment of differentiated thyroid carcinoma, the recommended dose is 24 mg taken once a day at approximately the same time every day. For treatment of hepatocellular carcinoma, the recommended daily dose is either 8 or 12 mg depending on bodyweight. 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 more information about using Lenvima, see the package leaflet or contact your doctor or pharmacist.

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.

Differentiated thyroid carcinoma

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.

Hepatocellular carcinoma

Lenvima has been shown to be at least as effective as the cancer medicine sorafenib at prolonging the time patients lived in one main study. The study involved 954 patients with hepatocellular carcinoma who had not previously been treated for their cancer and whose cancer could not be removed by surgery. Patients given Lenvima lived on average 13.6 months compared with 12.3 months in patients on sorafenib.

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, 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 in the brain, a syndrome known as ‘posterior reversible encephalopathy syndrome’ characterised by headache, confusion, fits and loss of vision, liver failure, hepatic encephalopathy (brain damage due to liver failure), stroke and heart attack. For the full list of side effects with Lenvima, see the package leaflet.

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

The European Medicines Agency decided that Lenvima’s benefits are greater than its risks and it can be authorised for use in the EU. In patients with differentiated thyroid carcinoma, the medicine showed a clinically relevant improvement in the time patients lived without their disease getting worse. In patients with advanced hepatocellular carcinoma who have a poor prognosis and few treatment options, Lenvima was as effective as sorafenib in prolonging their life. Regarding safety, the Agency considered that the majority of adverse effects with Lenvima can be adequately managed by reducing the dose or temporarily interrupting treatment.

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

As for all medicines, data on the use of Lenvima are continuously monitored. Side effects reported with Lenvima are carefully evaluated and any necessary action taken to protect patients.

Lenvima received a marketing authorisation valid throughout the EU on 28 May 2015