Tecentriq

atezolizumab

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

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

What is Tecentriq and what is it used for?

Tecentriq is a cancer medicine for treating urothelial carcinoma (a cancer of the bladder and urinary system) and a type of lung cancer called non-small cell lung cancer.

Tecentriq is used when these cancers are advanced or have spread to other parts of the body. For urothelial carcinoma, the medicine is for patients who have tried platinum chemotherapy before or are ineligible for treatment with cisplatin.

Patients with non-small cell lung cancer should first have had chemotherapy and those with certain genetic mutations (changes) that respond to targeted treatments should have those treatments before receiving Tecentriq.

Tecentriq contains the active substance atezolizumab.

How is Tecentriq used?

Tecentriq is given as an infusion (drip) into a vein every 3 weeks and treatment should continue for as long as the patient benefits from it or does not suffer from unmanageable side effects. Treatment may need to be stopped in patients experiencing certain side effects including inflammation in lungs, liver or bowel, problems with the thyroid and adrenal glands or the nerves, rashes and infusion reactions. For further information, see the package leaflet.

Tecentriq can only be obtained with a prescription and treatment should be started by a doctor experienced in treating cancer.

How does Tecentriq work?

The active substance in Tecentriq, atezolizumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand 1’ (PD-L1), which is present on the surface of many cancer cells.

PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. By attaching to PD-L1 and reducing its effects, Tecentriq increases the ability of the immune system to attack the cancer cells and thereby slow down the progression of the disease.

What benefits of Tecentriq have been shown in studies?

Urothelial carcinoma

Tecentriq has been shown to reduce tumours in patients with urothelial carcinoma that is advanced or has spread. In a study of 429 patients, 23% of patients who were not eligible for platinum chemotherapy responded to Tecentriq treatment and 16% of patients who had previously had platinum chemotherapy responded (a response is a partial or complete elimination of a patient’s tumours.)

Another study of 931 patients with urothelial carcinoma showed that patients given Tecentriq lived slightly longer (8.6 months) than patients given chemotherapy (8 months) although the difference could be due to chance. Response was seen even in patients whose cancer did not produce much PD-L1.

Non-small cell lung cancer

In patients with non-small cell lung cancer which is advanced or has spread, Tecentriq has been shown to be more effective than a comparator medicine at prolonging patients’ lives. In one main study of 850 patients, those patients given Tecentriq lived on average for 14 months while those given another cancer medicine, docetaxel, lived for an average of 10 months. Similar results were seen in a second lung cancer study of 287 patients where on average patients on Tecentriq lived for 13 months compared with 10 months for patients on docetaxel.

What are the risks associated with Tecentriq?

The most common side effects with Tecentriq (which may affect more than 1 in 10 people) are tiredness, reduced appetite, nausea (feeling sick) and vomiting, difficulty breathing, diarrhoea, rash, fever, joint pain, weakness and itching. For the full list of all side effects and restrictions, see the package leaflet.

Why is Tecentriq approved?

In urothelial carcinoma, Tecentriq has been shown to reduce tumour size in patients who have tried platinum chemotherapy or who are not eligible for such treatment. Tecentriq can also improve survival by 3 or 4 months in patients with non-small cell lung cancer who have few treatment options. Furthermore, its side effects are less troublesome than standard chemotherapy treatments and are considered manageable.

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

The company that markets Tecentriq will put in place an educational program for patients and healthcare professionals to explain that serious immune-related side effects can occur during treatment and what they should do to minimize risks. The company is also carrying out and completing studies to provide more data on the effectiveness of Tecentriq in urothelial carcinoma and on the medicine’s safety.

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

Other information about Tecentriq

The European Commission granted a marketing authorisation valid throughout the European Union for Tecentriq on 21 September 2017.

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

Name Language First published Last updated
Tecentriq : EPAR - Summary for the public BG = bălgarski 2017-09-29  
Tecentriq : EPAR - Summary for the public ES = español 2017-09-29  
Tecentriq : EPAR - Summary for the public CS = čeština 2017-09-29  
Tecentriq : EPAR - Summary for the public DA = dansk 2017-09-29  
Tecentriq : EPAR - Summary for the public DE = Deutsch 2017-09-29  
Tecentriq : EPAR - Summary for the public ET = eesti keel 2017-09-29  
Tecentriq : EPAR - Summary for the public EL = elliniká 2017-09-29  
Tecentriq : EPAR - Summary for the public EN = English 2017-09-29  
Tecentriq : EPAR - Summary for the public FR = français 2017-09-29  
Tecentriq : EPAR - Summary for the public IT = italiano 2017-09-29  
Tecentriq : EPAR - Summary for the public LV = latviešu valoda 2017-09-29  
Tecentriq : EPAR - Summary for the public LT = lietuvių kalba 2017-09-29  
Tecentriq : EPAR - Summary for the public HU = magyar 2017-09-29  
Tecentriq : EPAR - Summary for the public MT = Malti 2017-09-29  
Tecentriq : EPAR - Summary for the public NL = Nederlands 2017-09-29  
Tecentriq : EPAR - Summary for the public PL = polski 2017-09-29  
Tecentriq : EPAR - Summary for the public PT = português 2017-09-29  
Tecentriq : EPAR - Summary for the public RO = română 2017-09-29  
Tecentriq : EPAR - Summary for the public SK = slovenčina 2017-09-29  
Tecentriq : EPAR - Summary for the public SL = slovenščina 2017-09-29  
Tecentriq : EPAR - Summary for the public FI = suomi 2017-09-29  
Tecentriq : EPAR - Summary for the public SV = svenska 2017-09-29  
Tecentriq : EPAR - Summary for the public HR = Hrvatski 2017-09-29  

This EPAR was last updated on 29/09/2017 .

Authorisation details

Product details

Product details for Tecentriq
NameTecentriq
Agency product numberEMEA/H/C/004143
Active substance

atezolizumab

International non-proprietary name (INN) or common name

atezolizumab

Therapeutic area Carcinoma, Non-Small-Cell LungCarcinoma, Transitional Cell
Anatomical therapeutic chemical (ATC) code L01XC

Publication details

Publication details for Tecentriq
Marketing-authorisation holder

Roche Registration Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union21/09/2017

Contact address:

Roche Registration Limited
6 Falcon Way 
Shire Park
Welwyn
Garden City AL7 1TW 
United Kingdom

Product information

Product information

21/09/2017  Tecentriq -EMEA/H/C/004143 --

Name Language First published Last updated
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - Product Information HR = Hrvatski 2017-09-29  

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
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  
Tecentriq : EPAR - All Authorised presentations HR = Hrvatski 2017-09-29  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) after prior platinum-containing chemotherapy or who are considered cisplatin ineligible.

Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Patients with EGFR activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving Tecentriq.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Tecentriq : EPAR - Public assessment report HR = Hrvatski 2017-09-29 2017-10-11
CHMP summary of positive opinion for Tecentriq HR = Hrvatski 2017-07-21  

Authorised

This medicine is approved for use in the European Union