Tecentriq

RSS

atezolizumab

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

Overview

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

In urothelial cancer that is locally advanced or has spread, Tecentriq is used on its own in patients who have previously been treated with platinum-based cancer medicines or in patients who cannot be treated with cisplatin (a platinum-based medicine) and whose cancer cells (at least 5%) have a protein called PD-L1.

In non-small cell lung cancer that is locally advanced or has spread, Tecentriq is used on its own in patients who have had chemotherapy before. In patients whose cancer has spread and who have not yet had chemotherapy, Tecentriq is used in combination with the cancer medicines bevacizumab, paclitaxel and carboplatin. Patients with non-small cell lung cancer with certain genetic mutations (changes) should have targeted treatments before receiving Tecentriq.

Tecentriq contains the active substance atezolizumab.

This EPAR was last updated on 17/06/2019

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
5
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

05/03/2019 Tecentriq - EMEA/H/C/004143 - II/0007/G

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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

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