Tarceva

erlotinib

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This is a summary of the European public assessment report (EPAR) for Tarceva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tarceva.

What is Tarceva and what is it used for?

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.

How is Tarceva used?

Tarceva can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines. In patients who have not yet received chemotherapy, EGFR mutation testing should be performed before starting Tarceva therapy.

The medicine is available as tablets (25, 100 and 150 mg). For lung cancer, the recommended daily dose is 150 mg. For pancreatic cancer, it is 100 mg. Tarceva is taken at least one hour before or two hours after food. If needed (for example because of side effects), the dose may be reduced in 50 mg steps. As Tarceva seems to be more effective in patients with pancreatic cancer who develop a rash, treatment should be re‑assessed after four to eight weeks if no rash has developed. Patients taking Tarceva should stop smoking, as smoking can decrease the amount of the medicine in the blood.

How does Tarceva work?

The active substance in Tarceva, erlotinib, is a cancer medicine that belongs to the group ‘EGFR inhibitors’. Erlotinib blocks EGFRs, which can be found on the surface of some tumour cells. As a result of this block, the tumour cells can no longer receive the messages needed for growth, progression and spreading (metastasis). As a result, Tarceva helps to stop the cancer from growing, multiplying and spreading through the body.

How has Tarceva been studied?

NSCLC

In NSCLC, Tarceva has been mainly studied in four studies:

  • the first study compared Tarceva with chemotherapy in 173 patients with advanced NSCLC with activating EGFR mutations who had not received previous chemotherapy. Patients taking Tarceva lived without their disease getting worse for an average of 10.4 months compared with 5.1 months for those receiving chemotherapy medicines.
  • the second study compared Tarceva with placebo (a dummy treatment) in 889 patients with advanced or metastatic NSCLC whose disease had not got worse following an initial course of treatment with 4 cycles of platinum-containing chemotherapy. Overall, Tarceva caused a marginal increase in how long the patients lived without their disease getting worse and in how long they survived. The greatest benefit was observed in a subgroup of 49 patients with EGFR activating mutations: those taking Tarceva (22 patients) lived for an average of 44.6 weeks without their disease getting worse, compared with 13 weeks for those taking placebo (27 patients).
  • a third study compared Tarceva with placebo in 643 patients with advanced NSCLC whose cancer cells did not have EGFR activating mutations and whose disease was stable after initial treatment with 4 cycles of platinum-containing chemotherapy. The study compared how long patients survived when Tarceva was used early in the study with how long they survived when Tarceva was used later in the study. The study found no advantage to early use of the medicine, as patients treated with Tarceva early in the study did not live longer than those treated with Tarceva later in the study (after the disease had progressed).
  • the fourth study compared Tarceva with placebo in 731 patients who had not responded to at least one previous chemotherapy treatment. Patients taking Tarceva survived for an average of 6.7 months, compared with 4.7 months for the patients taking placebo. Among the patients who took Tarceva, the average survival was 8.6 months in those whose tumours were ‘EGFR IHC-positive’ (had EGFRs on the cell surface), and 5.0 months in those whose tumours were EGFR IHC-negative.

Pancreatic cancer

In pancreatic cancer, Tarceva in combination with gemcitabine has been studied in 569 patients with pancreatic cancer that was advanced, unresectable (that cannot be removed by surgery) or metastatic. Patients with metastatic cancer taking Tarceva as initial therapy lived without their disease getting worse for an average of 5.9 months, compared with 5.1 months in those taking placebo. However, there was no advantage for patients whose cancer had not spread beyond the pancreas.

What is the risk associated with Tarceva?

In studies, the most common side effects with Tarceva when used as monotherapy for lung cancer were rash (seen in 75% of patients), diarrhoea (seen in 54% of patients), loss of appetite and tiredness (each seen in 52% of patients). In the study of Tarceva used in combination with gemcitabine for pancreatic cancer, the most common side effects were tiredness (seen in 73% of patients), rash (seen in 69% of patients) and diarrhoea (seen in 48% of patients). For the full list of side effects and restrictions with Tarceva, see the package leaflet.

Why has Tarceva been approved?

The European Medicines Agency decided that Tarceva’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Tarceva?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tarceva have been included in the summary of product characteristics and the package leaflet.

Other information about Tarceva

The European Commission granted a marketing authorisation valid throughout the European Union for Tarceva on 19 September 2005.

For more information about treatment with Tarceva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Tarceva : EPAR - Summary for the public BG = bălgarski 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public ES = español 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public CS = čeština 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public DA = dansk 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public DE = Deutsch 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public ET = eesti keel 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public EL = elliniká 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public EN = English 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public FR = français 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public IT = italiano 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public LV = latviešu valoda 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public LT = lietuvių kalba 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public HU = magyar 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public MT = Malti 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public NL = Nederlands 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public PL = polski 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public PT = português 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public RO = română 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public SK = slovenčina 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public SL = slovenščina 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public FI = suomi 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public SV = svenska 2007-08-17 2018-03-26
Tarceva : EPAR - Summary for the public HR = Hrvatski 2007-08-17 2018-03-26

This EPAR was last updated on 28/03/2018 .

Authorisation details

Product details

Product details for Tarceva
NameTarceva
Agency product numberEMEA/H/C/000618
Active substance

erlotinib

International non-proprietary name (INN) or common name

erlotinib

Therapeutic area Carcinoma, Non-Small-Cell LungPancreatic Neoplasms
Anatomical therapeutic chemical (ATC) code L01XE03

Publication details

Publication details for Tarceva
Marketing-authorisation holder

Roche Registration Limited

Revision25
Date of issue of marketing authorisation valid throughout the European Union19/09/2005

Contact address:

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Product information

Product information

22/02/2018  Tarceva -EMEA/H/C/000618 -II/0052

Name Language First published Last updated
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28
Tarceva : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-03-28

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.


Name Language First published Last updated
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  
Tarceva : EPAR - All Authorised presentations HR = Hrvatski 2005-11-02  

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

Initial marketing-authorisation documents

Name Language First published Last updated
Tarceva : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-11-02  
Tarceva : EPAR - Scientific Discussion HR = Hrvatski 2005-11-02  

Authorised

This medicine is approved for use in the European Union

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