Tecentriq
atezolizumab
Table of contents
Overview
Tecentriq is a medicine for treating the following cancers:
- urothelial cancer (cancer of the bladder and urinary system)
- lung cancer
- a type of breast cancer known as triple-negative breast cancer
- hepatocellular carcinoma, a cancer that starts in the liver.
Tecentriq is used either on its own or in combination with other cancer treatments for cancers that are advanced or have spread to other parts of the body. For urothelial and breast cancers, cancer cells must have a certain amount of a protein called PD-L1. For more information about the use of Tecentriq, see the package leaflet.
Tecentriq contains the active substance atezolizumab.
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List item
Tecentriq : EPAR - Medicine overview (PDF/121.55 KB) (updated)
First published: 29/09/2017
Last updated: 23/02/2021
EMA/513651/2020 -
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Tecentriq : EPAR - Risk-management-plan summary (PDF/167.78 KB) (updated)
First published: 23/10/2019
Last updated: 23/02/2021
Authorisation details
Product details | |
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Name |
Tecentriq
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Agency product number |
EMEA/H/C/004143
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Active substance |
atezolizumab
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International non-proprietary name (INN) or common name |
atezolizumab
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
L01XC
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Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Roche Registration GmbH
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Revision |
13
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Date of issue of marketing authorisation valid throughout the European Union |
20/09/2017
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Contact address |
Product information
23/02/2021 Tecentriq - EMEA/H/C/004143 - IB/0056
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.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Urothelial carcinoma
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, and whose tumours have a PD-L1 expression ≥ 5%.
Non-small cell lung cancer
Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving Tecentriq.
Tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK positive NSCLC
Small cell lung cancer
Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Hepatocellular carcinoma
Tecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Hepatocellular carcinoma
Tecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
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, and whose tumours have a PD-L1 expression ≥ 5%.
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving Tecentriq.
Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 202129/01/2021
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 202011/12/2020
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01/10/2020
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18/09/2020
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26/07/2019
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28/06/2019
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 201901/02/2019
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16/11/2018
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01/06/2018
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01/06/2018
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21/07/2017