Tarceva

RSS

erlotinib

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

Overview

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 for:

  • previously untreated patients whose cancer cells have certain changes (‘activating mutations’) in the gene for a protein called epidermal growth factor receptor (EGFR);
  • patients with EGFR activating mutations whose disease is stable after initial chemotherapy. Stable means that the cancer has neither improved nor worsened with chemotherapy (medicines to treat cancer);
  • patients with EGFR activating mutations in whom previous chemotherapy has not worked;
  • patients without EGFR activating mutations in whom previous chemotherapy has not worked and other treatments are 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 16/05/2023

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
L01EB02
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
32
Date of issue of marketing authorisation valid throughout the European Union
19/09/2005
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

16/03/2023 Tarceva - EMEA/H/C/000618 - II/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:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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

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

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