Tecentriq

RSS

atezolizumab

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 05/03/2021

Authorisation details

Product details
Name
Tecentriq
Agency product number
EMEA/H/C/004143
Active substance
atezolizumab
International non-proprietary name (INN) or common name
atezolizumab
Therapeutic area (MeSH)
  • Carcinoma, Transitional Cell
  • Carcinoma, Non-Small-Cell Lung
  • Urologic Neoplasms
  • Breast Neoplasms
  • Small Cell Lung Carcinoma
Anatomical therapeutic chemical (ATC) code
L01XC
Additional monitoringAdditional 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
Marketing-authorisation holder
Roche Registration GmbH
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
20/09/2017
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

23/02/2021 Tecentriq - EMEA/H/C/004143 - IB/0056

Contents

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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

Changes since initial authorisation of medicine

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