Author: Roche Registration Ltd.


Long information

What is it?

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).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it 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 patients whose disease is stable after receiving their first four cycles of standard chemotherapy medicines to treat cancer that includes a platinum-containing medicine. Stable means that the cancer had neither improved nor got worse during the chemotherapy

it is also used to treat patients when at least one previous chemotherapy treatment has failed.

Tarceva has not been shown to be effective in patients whose lung cancer is ?epidermal growth factor receptor (EGFR)-negative?. ?EGFR-negative? means that EGFRs 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 it used?

Treatment with Tarceva should be supervised by a doctor who has experience of the use of anticancer medicines.

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 it 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 it been studied?

Tarceva has been compared with placebo (a dummy treatment) in three main studies:

two of the studies were in patients with non-small cell lung cancer one involved 889 patients whose disease had not got worse following four cycles of platinum-containing chemotherapy, 487 of whom had stable disease and the other involved 731 patients who had not responded to at least one previous chemotherapy treatment

one study looked at Tarceva in combination with gemcitabine 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 benefits has it shown during the studies?

For lung cancer, the study in patients who had received platinum-containing chemotherapy showed that 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 study of 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-positive? (had EGFRs on their surface), and 5.0 months in those whose tumours were EGFR-negative.

For metastatic pancreatic cancer, the patients taking Tarceva survived 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?

In studies, the most common side effects with Tarceva when used for lung cancer (seen in more than 1 patient in 10) were infection, loss of appetite, keratoconjunctivitis sicca (dry eyes), conjunctivitis (inflammation of the membrane that lines the eyelid), dyspnoea (difficulty breathing), cough, diarrhoea, nausea (feeling sick), vomiting, stomatitis (inflammation of the lining of the mouth), abdominal pain (stomach ache), rash, pruritus (itching), dry skin and fatigue (tiredness). In studies of Tarceva used in combination with gemcitabine for pancreatic cancer, the most common side effects (seen in more than 1 patient in 10) were infection, decreased weight, depression, neuropathy (nerve damage), headache, cough, diarrhoea, stomatitis, dyspepsia (heartburn), flatulence (gas), rash, alopecia (hair loss), fatigue, pyrexia (fever) and rigors (shaking chills). Abnormal liver test results have also been seen in more than 1 patient in 10 treated with Tarceva. Patients with persistent and severe diarrhoea 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 should not be used in people who may be hypersensitive (allergic) to erlotinib or any of the other ingredients.

Why has it been approved?

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

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