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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/506646/2012

EMEA/H/C/000798

EPAR summary for the public

Tasigna

nilotinib

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

What is Tasigna?

Tasigna is a medicine containing the active substance nilotinib. It is available as capsules (150 and 200 mg).

What is Tasigna used for?

Tasigna is used to treat adults with chronic myelogenous leukaemia (CML), a type of cancer of the white blood cells. It is used when the patient is 'Philadelphia chromosome positive' (Ph+), which means that some of the patient's genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome. This chromosome produces an enzyme, called Bcr-Abl kinase, that leads to the development of leukaemia.

Tasigna is used to treat the 'chronic' and 'accelerated' phases of CML, in patients who cannot tolerate other treatments including imatinib (another anticancer medicine), or when their disease is not responding to them. There is no information available on its effectiveness in patients whose disease is in 'blast crisis' (another phase of CML).

Tasigna is also used in newly diagnosed patients with CML in the chronic phase.

Because the number of patients with CML is low, the disease is considered 'rare', and Tasigna was designated an 'orphan medicine' (a medicine used in rare diseases) on 22 May 2006.

The medicine can only be obtained with a prescription.

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How is Tasigna used?

Treatment with Tasigna should be initiated by a doctor who has experience in the diagnosis and treatment of CML.

In newly diagnosed patients with chronic phase CML, the recommended dose of Tasigna is 300 mg twice a day. In patients with chronic or accelerated phase CML who cannot tolerate other treatments or whose disease does not respond to them, the recommended dose is 400 mg twice a day.

Treatment should continue for as long as the patient continues to benefit. The dose should be reduced or treatment interrupted if the patient has certain side effects affecting the blood.

The two doses of Tasigna should be taken around 12 hours apart. The capsules should be swallowed whole with a glass of water, without eating anything for two hours before and one hour after each dose. For patients who are unable to swallow capsules, the content of the capsules may be dispersed in a teaspoon of apple puree and taken immediately. Tasigna can be given with certain other medicines if appropriate.

How does Tasigna work?

The active substance in Tasigna, nilotinib, belongs to a group of medicines called 'protein kinase inhibitors'. These compounds act by blocking types of enzymes known as protein kinases. Nilotinib acts by blocking the protein kinase called Bcr-Abl kinase. This enzyme is produced by leukaemia cells, and causes them to multiply uncontrollably. By blocking Bcr-Abl kinase, Tasigna helps to control the spread of leukaemia cells.

How has Tasigna been studied?

Tasigna has been studied in two main studies involving a total of 439 patients with CML, who could not tolerate imatinib or whose disease had stopped responding to it. In these studies, Tasigna was not compared with any other treatment. The first study included a total of 320 patients whose disease was in the 'chronic phase', three quarters of whom had stopped responding to imatinib. Its main measure of effectiveness was the proportion of patients who had had a 'major cytogenetic response' (when the proportion of the patient's white blood cells that contained the Philadelphia chromosome had fallen to below 35%). The second study included a total of 119 patients whose disease was in the 'accelerated phase', four fifths of whom had stopped responding to imatinib. Its main measure of effectiveness was the proportion of patients who had had a 'haematological response' (a return to normal of the number of white cells in the blood).

In a third main study in 846 newly diagnosed patients with chronic phase CML, Tasigna, either as 300 mg twice a day or as 400 mg twice a day, was compared with imatinib. The main measure of effectiveness was the proportion of patients who had had a 'major molecular response' (when the proportion of the patient's white blood cells that contained the Philadelphia chromosome had fallen to below 0.1%) after 12 months of treatment.

What benefit has Tasigna shown during the studies?

In the study in chronic phase CML patients who could not tolerate imatinib or whose disease had stopped responding to it, 156 (49%) of the 320 patients had a major cytogenetic response after having received Tasigna for an average of 341 days (around eleven months). In the study of accelerated phase CML, 50 (42%) of the 119 patients had a haematological response, after having received Tasigna for an average of 202 days (around seven months). In both studies, Tasigna had a similar effect in patients who could not tolerate imatinib and those whose disease had stopped responding to it.

In the study in newly diagnosed patients with chronic phase CML, Tasigna was more effective than imatinib at reducing the number of white blood cells containing the Philadelphia chromosome: 125 (44%) of the 282 patients taking Tasigna 300 mg twice a day and 120 (42.7%) of the 281 patients taking Tasigna 400 mg twice a day had a major molecular response compared with 63 (22.3%) of the 283 patients taking imatinib.

What is the risk associated with Tasigna?

The most common side effects with Tasigna (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), neutropenia (low white blood cell counts), anaemia (low red blood cell counts), headache, nausea (feeling sick), rash, pruritus (itching), myalgia (muscle pain) and fatigue (tiredness). For the full list of all side effects reported with Tasigna, see the package leaflet.

Tasigna must not be used in people who are hypersensitive (allergic) to nilotinib or any of the other ingredients.

Why has Tasigna been approved?

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

What measures are being taken to ensure the safe use of Tasigna?

The company that makes Tasigna will provide an information pack in each Member State for doctors and pharmacists who will prescribe or dispense the medicine. The pack will remind them of how Tasigna should be used safely in patients.

Other information about Tasigna

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

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

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

This summary was last updated in 08-2012.

Tasigna

EMA/506646/2012

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