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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/867620/2015

EMEA/H/C/004124

EPAR summary for the public

Tagrisso

osimertinib

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

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

What is Tagrisso and what is it used for?

Tagrisso is a cancer medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC).

Tagrisso is used in patients whose cancer is advanced or has spread and who have the T790M mutation, a particular change in the gene for a protein called epidermal growth factor receptor (EGFR).

It contains the active substance osimertinib.

How is Tagrisso used?

Treatment with Tagrisso should be started and supervised by a doctor who is experienced in the use of cancer medicines. Before starting treatment, doctors must have confirmation that their patients have the T790M mutation. This should be done by genetic testing in an appropriate laboratory.

Tagrisso is available as tablets (40 and 80 mg). The recommended dose is 80 mg once a day. Treatment with Tagrisso may continue for as long as the disease improves or remains stable and the side effects are tolerable. If certain side effects develop the doctor may decide to reduce the dose or stop treatment.

For further information, see the summary of product characteristics (also part of the EPAR).

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How does Tagrisso work?

The active substance in Tagrisso, osimertinib, is a type of cancer medicine called tyrosine kinase inhibitor. It blocks the activity of EGFR, which normally controls growth and division of cells. In lung cancer cells, EGFR is often overactive, causing uncontrolled division of cancer cells. By blocking EGFR, osimertinib helps to reduce the growth and spread of the cancer.

Unlike most other tyrosine kinase inhibitors, Tagrisso is active against cancer cells with the T790M mutation in the EGFR gene.

What benefits of Tagrisso have been shown in studies?

Tagrisso has been investigated in two main studies involving 411 patients who had the T790M mutation and in whom the disease progressed despite previous treatment with EGFR tyrosine kinase inhibitors. In both studies, which were still ongoing at the time of Tagrisso's initial evaluation, the medicine was not compared with any other treatment. The main measure of effectiveness was the proportion of patients who responded to treatment (objective response rate) and whose tumour shrank, which was assessed using body scans and standardised criteria for solid tumours. Combining both studies, the overall response rate at the time of analysis was 66% (263 out of 398 patients) and preliminary data suggest that the average length of response was 8.5 months.

What are the risks associated with Tagrisso?

The most common side effects with Tagrisso (which may affect more than 1 in 10 people) are diarrhoea, rash, dry skin, paronychia (nail bed infection), pruritus (itching), stomatitis (inflammation of the lining of the mouth) and a decrease in the levels of white blood cells and platelets.

Tagrisso must not be used together with St. John's wort (a herbal preparation used to treat depression). For the full list of all restrictions and side effects reported with Tagrisso, see the package leaflet.

Why is Tagrisso approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tagrisso's benefits are greater than its risks and recommended that it be approved for use in the EU.

Patients with the T790M mutation currently have a poor prognosis and very limited treatment options; therefore there is a high unmet medical need. The evidence available so far showed promising results in terms of Tagrisso's ability to reduce tumour size. Although Tagrisso has only been investigated in patients with the T790M mutation who were previously treated with EGFR tyrosine kinase inhibitors, Tagrisso is also expected to be effective in patients with the T790M mutation who have not previously received these medicines. Regarding safety, the adverse effects with Tagrisso are similar to other medicines of the same class and are considered acceptable.

Tagrisso has been given 'conditional approval'. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Tagrisso?

Since Tagrisso has been granted a conditional approval, the company that markets Tagrisso will provide the findings of a study comparing Tagrisso with platinum-based chemotherapy (standard treatment for NSCLC).

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

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

The European Commission granted a marketing authorisation valid throughout the European Union for Tagrisso on 2 February 2016.

The full EPAR and risk management plan summary for Tagrisso 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 Tagrisso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 02-2016.

Tagrisso

EMA/867620/2015

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