Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 14 August 2018

Indication(s)

Non-Small Cell Lung Cancer (NSCLC):
Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.

Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC 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 NSCLC 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.

No survival advantage could be shown for patients with locally advanced disease.

Full Prescribing information

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Fluid Management

Fluid Management

Are you up-to-date with the latest evidence of effective procedures for fluid management?

+ 2 more

Chronic Lymphocytic Leukaemia (CLL)

Chronic Lymphocytic Leukaemia (CLL)

Refine your knowledge of chronic lymphocytic leukaemia (CLL) with information on pathophysiology, diagnosis, treatment options and more

+ 1 more

Biosimilars in Oncology Knowledge Centre

Biosimilars in Oncology Knowledge Centre

What are biologics and how do they differ from small molecule medicines? Discover more about their development, as well as the manufacturing and regulatory processes in the Biosimilars in Oncology Knowledge Centre.

Load more

Related Content

More information

Category Value
Agency product number EMEA/H/C/000618
Orphan designation No
Date First Approved 19-09-2005
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Roche Registration GmbH