Tecentriq

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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);

• non-small cell lung cancer (NSCLC) when the disease is early-stage or metastatic (has spread to other parts of the body);

• small cell lung cancer (SCLC);

• 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 treatments for cancers that are advanced or have spread to other parts of the body. In some cases, it is used after surgery or after other cancer treatments.

The doctor may need to confirm that the cancer cells produce a certain amount of a protein called PD-L1, and that particular genetic mutations known to reduce the medicine’s effectiveness are not present. For more information about the use of Tecentriq, see the package leaflet.

Tecentriq contains the active substance atezolizumab.

This EPAR was last updated on 24/08/2022

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
L01XC32
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
20
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

25/07/2022 Tecentriq - EMEA/H/C/004143 - IB/0071

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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% (see section 5.1).

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 (see section 5.1).

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 (see section 5.1).

Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC (see section 5.1).

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 (see section 5.1).

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) (see section 5.1).

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 (see section 5.1).

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% (see section 5.1).

Non-small cell lung cancer
Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC (see section 5.1).

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 (see section 5.1).

Triple-negative breast cancer
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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