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 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).

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.

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

This EPAR was last updated on 13/10/2016 .

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.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Tagrisso
Marketing-authorisation holder

AstraZeneca AB

Revision2
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

15/09/2016  Tagrisso -EMEA/H/C/004124 -II/0003

Name Language First published Last updated
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13
Tagrisso : EPAR - Product Information EN = English 2016-02-17 2016-10-13

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 2016-10-13

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