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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/605815/2012

EMEA/H/C/000799

EPAR summary for the public

Torisel

temsirolimus

This is a summary of the European public assessment report (EPAR) for Torisel. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Torisel.

What is Torisel?

Torisel is a concentrate and diluent that are made up into a solution for infusion (drip into a vein). It contains the active substance temsirolimus.

What is Torisel used for?

Torisel is used to treat patients with the following types of cancer:

•    advanced renal cell carcinoma (a type of kidney cancer). 'Advanced' means that the cancer has started to spread;

•    mantle cell lymphoma (an aggressive cancer of a type of white blood cell called B lymphocytes). Torisel is used in adults when the lymphoma has come back after previous treatment or has not responded to other treatments.

Because the numbers of patients with renal cell carcinoma and mantle cell lymphoma are low, the diseases are considered 'rare', and Torisel was designated an 'orphan medicine' (a medicine used in rare diseases) on 6 April 2006 (for renal cell carcinoma) and on 6 November 2006 (for mantle cell lymphoma).

The medicine can only be obtained with a prescription.

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How is Torisel used?

Torisel must be given under the supervision of a doctor who has experience in the use of anticancer medicines. For renal cell carcinoma, the recommended dose is 25 mg once a week, but a 10-mg dose is recommended in patients with severe liver problems who have high levels of platelets in the blood before treatment. For mantle cell lymphoma, the recommended dose is 175 mg once a week for three weeks, followed by weekly doses of 75 mg.

Torisel is given as an infusion lasting 30 to 60 minutes. Patients should receive an antihistamine to prevent an allergic reaction around 30 minutes before each dose of Torisel. Treatment with Torisel should continue until the patient does not benefit from the medicine any more or has unacceptable side effects. Some side effects can be managed by interrupting treatment or reducing the dose.

How does Torisel work?

The active substance in Torisel, temsirolimus, is an anticancer medicine, which acts by blocking a protein called 'mammalian target of rapamycin' (mTOR). In the body, temsirolimus attaches to a protein that is found inside cells to make a 'complex'. This complex then blocks mTOR. Since mTOR is involved in the control of cell division, Torisel prevents the division of cancer cells, slowing down the growth and spread of the cancer.

How has Torisel been studied?

In advanced renal cell carcinoma, Torisel has been studied in one main study involving 626 patients who had a poor prognosis. The study compared 25 mg Torisel with interferon alfa (another anticancer medicine) and with 15 mg Torisel in combination with interferon alfa. The main measure of effectiveness was how long the patients survived. In mantle cell lymphoma, Torisel has been studied in 162 patients whose disease had come back after previous treatment or had not responded to other treatments. Each patient received one of two doses of Torisel or the most appropriate alternative treatment chosen by the investigator from a list of medicines commonly used to treat this type of cancer such as gemcitabine or fludarabine. The main measure of effectiveness was how long the patients lived without the disease getting worse.

What benefit has Torisel shown during the studies?

Torisel was more effective than the comparator treatments. In advanced renal cell carcinoma, patients receiving Torisel alone survived for an average of 10.9 months, compared with 7.3 months in those receiving interferon alfa alone. The patients receiving the lower dose of Torisel in combination with interferon alfa survived for a similar length of time (8.4 months) as those taking interferon alfa alone. In mantle cell lymphoma, patients receiving the approved dose of Torisel lived for an average of 4.8 months without their disease getting worse, compared with 1.9 months in those receiving the alternative treatment.

What is the risk associated with Torisel?

The most common side effects with Torisel (seen in more than 1 patient in 10) are bacterial and viral infections, pneumonia (infection of the lungs), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), hypokalaemia (low blood potassium levels), decreased appetite, hyperglycaemia (high blood sugar levels), hypercholesterolaemia (high blood cholesterol levels), hypertriglyceridemia (high blood levels of certain fats), headache, insomnia (difficulty sleeping), dysgeusia (taste disturbances), dyspnoea

Torisel

(difficulty breathing), epistaxis (nose bleeds), cough, abdominal pain (stomach ache), vomiting, stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), constipation, rash, pruritus (itching), dry skin, back pain, arthralgia (joint pain), oedema (swelling),fatigue, asthenia (weakness), pain, pyrexia (fever), mucosal inflammation (inflammation of the moist body surfaces), chest pain, chills and increased blood creatinine levels (a marker of kidney problems). For the full list of all side effects reported with Torisel, see the package leaflet.

Torisel must not be used in people who are hypersensitive (allergic) to temsirolimus, to its metabolites (the substances that it is broken down into) including sirolimus (a medicine used to prevent rejection of transplanted kidneys), to polysorbate 80 or to any of the other ingredients of the medicine. Torisel is not recommended in patients with mantle cell lymphoma who have moderate or severe problems with their liver.

Why has Torisel been approved?

The CHMP decided that Torisel's benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Torisel

The European Commission granted a marketing authorisation valid throughout the European Union for Torisel on 19 November 2007.

The full EPAR for Torisel 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 Torisel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The summary of the opinion of the Committee for Orphan Medicinal Products for Torisel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.

This summary was last updated in 09-2012.

Torisel

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