Tagrisso

osimertinib

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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 confirm that their patients have the T790M mutation by genetic testing in an appropriate laboratory.

Tagrisso is available as tablets (40 and 80 mg) to be taken by mouth. 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 package leaflet.

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 shown to be effective at shrinking tumors in patients with the T790M mutation and at slowing down the worsening of the cancer.

In two studies involving 411 patients, the overall response rates (the proportion of patients whose tumours shrank) with Tagrisso was 66% and the average length of time the response lasted was 12.5 months. In these studies, Tagrisso was not compared with any other treatment.

A third study in 419 patients looked mainly at how effective Tagrisso was at preventing the cancer from worsening, comparing it with a platinum-based chemotherapy (the standard treatment for NSCLC). In patients taking Tagrisso, the cancer did not get worse for around 10.1 months compared with 4.4 months in patients on chemotherapy.

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 with Tagrisso, see the package leaflet

Why is Tagrisso approved?

Patients with the T790M mutation have a poor prognosis and limited treatment options; therefore there is a high unmet medical need. Tagrisso has been shown in studies to be effective at shrinking tumors in patients with this mutation and at slowing down the worsening of the cancer. Regarding safety, the adverse effects with Tagrisso are similar to other medicines of the same class and are considered acceptable.

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

Tagrisso was originally given ‘conditional approval’ because there was more evidence to come about the medicine. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.

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

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

Other information about Tagrisso

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Tagrisso on 2 February 2016. This was switched to a full marketing authorisation on 24 April 2017.

For more information about treatment with Tagrisso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Tagrisso : EPAR - Summary for the public BG = bălgarski 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public ES = español 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public CS = čeština 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public DA = dansk 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public DE = Deutsch 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public ET = eesti keel 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public EL = elliniká 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public FR = français 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public IT = italiano 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public LV = latviešu valoda 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public LT = lietuvių kalba 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public HU = magyar 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public MT = Malti 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public NL = Nederlands 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public PL = polski 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public PT = português 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public RO = română 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public SK = slovenčina 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public SL = slovenščina 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public FI = suomi 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public SV = svenska 2016-02-17 2017-05-16
Tagrisso : EPAR - Summary for the public HR = Hrvatski 2016-02-17 2017-05-16
Name Language First published Last updated
Tagrisso : EPAR - Risk-management-plan summary (English only) 2016-03-02  

This EPAR was last updated on 16/05/2017 .

Authorisation details

Product details

Product details for Tagrisso
NameTagrisso
Agency product numberEMEA/H/C/004124
Active substance

osimertinib mesylate

International non-proprietary name (INN) or common name

osimertinib

Therapeutic area Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code L01XE
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Tagrisso
Marketing-authorisation holder

AstraZeneca AB

Revision5
Date of issue of marketing authorisation valid throughout the European Union02/02/2016

Contact address:

AstraZeneca AB 
SE 151-85 Södertälje 
Sweden

Product information

Product information

24/04/2017  Tagrisso -EMEA/H/C/004124 -II/0009/G

Name Language First published Last updated
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2017-05-16

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12
Tagrisso : EPAR - All Authorised presentations EN = English 2016-02-17 2016-04-12

Pharmacotherapeutic group

Other antineoplastic agents, protein kinase inhibitors

Therapeutic indication

Tagrisso is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Tagrisso : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-04-12 2017-05-16
Tagrisso-H-C-4124-II-0009-G : EPAR - Assessment Report - Variation EN = English 2017-05-16  

Initial marketing-authorisation documents

Name Language First published Last updated
Tagrisso : EPAR - Public assessment report EN = English 2016-02-17  
CHMP summary of opinion for Tagrisso EN = English 2015-12-18