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Active Substance: erlotinib
Common Name: erlotinib
ATC Code: L01XE03
Marketing Authorisation Holder: Roche Registration Limited
Active Substance: erlotinib
Status: Authorised
Authorisation Date: 2005-09-19
Therapeutic Area: Carcinoma, Non-Small-Cell Lung Pancreatic Neoplasms
Pharmacotherapeutic Group: Antineoplastic agents

Therapeutic Indication

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 as monotherapy for maintenance treatment in patients with locally advanced or metastatic NSCLC with stable disease after four cycles of standard platinum-based 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.

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 (see section 5.1).

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 (see sections 4.2 and 5.1).

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

What is Tarceva?

Tarceva is a medicine that contains the active substance erlotinib. It is available as white to pale yellow round tablets (25, 100 and 150 mg).

What is Tarceva used for?

Tarceva is used in advanced or metastatic non-small-cell lung cancer. ‘Advanced’ means the cancer has started to spread and ‘metastatic’ means that it has already spread to other parts of the body. It is used in the following patients:

  • patients whose cancer cells have certain mutations in the gene for a protein called epidermal growth factor receptor and who have not received previous chemotherapy (medicines to treat cancer);
  • patients whose disease is stable after receiving their first four cycles of standard chemotherapy that includes a platinum-containing medicine. ‘Stable’ means that the cancer had neither improved nor worsened during the chemotherapy;
  • patients who have had at least one previous chemotherapy treatment that has failed.

Tarceva has not been shown to be effective in patients whose lung cancer is ‘epidermal-growth-factor-receptor (EGFR) IHC-negative’. ‘EGFR IHC-negative’ means that the EGFR receptor protein cannot be detected on the surface of the cancer cells, or can only be detected in small quantities.

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

For both lung cancer and pancreatic cancer, doctors should take the patient’s chances of survival into account when prescribing Tarceva.

The medicine can only be obtained with a prescription.

How is Tarceva used?

Treatment with Tarceva should be supervised by a doctor who has experience in the use of anticancer medicines. In patients who have not yet received chemotherapy, EGFR mutation testing should be performed before starting Tarceva therapy.

For lung cancer, the recommended daily dose of Tarceva 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 an anticancer 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?

In non-small-cell lung cancer, Tarceva has been compared with placebo (a dummy treatment) in three main studies:

  • the first involved 889 patients with non-small-cell lung cancer whose disease had not got worse following four cycles of platinum-containing chemotherapy, 487 of whom had stable disease;
  • the second study involved 731 patients who had not responded to at least one previous chemotherapy treatment;
  • the third study compared Tarceva with other chemotherapy in 173 patients with advanced non-small-cell lung cancer with EGFR mutations who had not received previous chemotherapy;

In pancreatic cancer Tarceva in combination with gemcitabine has been studied in 569 patients with pancreatic cancer that was advanced, unresectable (unable to be removed by surgery) or metastatic.

In all of the studies, the main measure of effectiveness was how long the patients lived without their cancer getting worse or how long they survived.

What benefit has Tarceva shown during the studies?

In the first study, in lung-cancer patients who had received platinum-containing chemotherapy, Tarceva caused a marginal increase in how long the patients lived without their disease getting worse and in how long they survived. Among the patients whose disease was stable, the patients taking Tarceva lived for an average of 12.1 weeks without their disease getting worse, compared with 11.3 weeks in those taking placebo, and survival times were 11.9 months, on average, with Tarceva and 9.6 months with placebo.

In the second study, in lung-cancer patients who had not responded to previous chemotherapy, the 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 their surface), and 5.0 months in those whose tumours were EGFR IHC-negative.

In the third study, in lung cancer patients with EGFR mutations, patients taking Tarceva as initial treatment survived without their disease getting worse for an average of 9.7 months compared with 5.2 months for those receiving other chemotherapy medicines.

In the study in metastatic pancreatic cancer, the patients taking Tarceva as initial therapy survived 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) and loss of appetite (seen in 52% of patients). In the study of Tarceva used in combination with gemcitabine for pancreatic cancer, the most common side effects were fatigue (seen in 73% of patients), rash (seen in 69% of patients) and diarrhoea (seen in 48% of patients). Patients with persistent and severe diarrhoea, nausea, loss of appetite, or vomiting should contact their doctor, as they may be at risk of low blood potassium levels and kidney failure. They may need to be treated in hospital. For the full list of side effects reported with Tarceva, please see the package leaflet.

Tarceva must not be used in people who are hypersensitive (allergic) to erlotinib or any of the other ingredients.

Why has Tarceva been approved?

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

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.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.