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.

Tecentriq is used for cancers that are advanced or have spread to other parts of the body either on its own or in combination with other cancer treatments. 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 23/10/2019

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
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
6
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

03/09/2019 Tecentriq - EMEA/H/C/004143 - II/0018; II/0019

Contents

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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, and whose tumours have a PD-L1 expression ≥ 5%.

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 NSLCLC should also have received targeted therapy before receiving Tecentriq.

Assessment history

Changes since initial authorisation of medicine

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