Tarceva

RSS

erlotinib

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

Overview

An overview of Tarceva and why it is authorised in the EU

Tarceva is a cancer medicine used in non‑small-cell lung cancer (NSCLC) that is advanced (the cancer has started to spread) or metastatic (it has already spread to other parts of the body). It is used in the following patients:

  • patients whose cancer cells have certain changes (‘activating mutations’) in the gene for a protein called epidermal growth factor receptor (EGFR) and have not received previous chemotherapy (medicines to treat cancer);
  • patients with EGFR activating mutations whose disease is stable after initial chemotherapy. Stable means that the cancer had neither improved nor worsened with chemotherapy;
  • patients with EGFR activating mutations who have had at least one previous chemotherapy treatment that has failed;
  • patients without EGFR activating mutations who have had at least one previous chemotherapy treatment that has failed and when other treatments are considered unsuitable.

Tarceva is also used in patients with metastatic pancreatic cancer, in combination with gemcitabine (another cancer medicine).

The medicine contains the active substance erlotinib.

This EPAR was last updated on 07/09/2018

Authorisation details

Product details
Name
Tarceva
Agency product number
EMEA/H/C/000618
Active substance
erlotinib
International non-proprietary name (INN) or common name
erlotinib
Therapeutic area (MeSH)
  • Carcinoma, Non-Small-Cell Lung
  • Pancreatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XE03
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
28
Date of issue of marketing authorisation valid throughout the European Union
18/09/2005
Contact address
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

09/08/2018 Tarceva - EMEA/H/C/000618 - N/0060

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

Non-small cell lung cancer (NSCLC)

Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy.

Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.

When prescribing Tarceva, factors associated with prolonged survival should be taken into account.

No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours.

Pancreatic cancer

Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.

When prescribing Tarceva, factors associated with prolonged survival should be taken into account.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating