Product Specific Fact Sheet - Conditional Approval of Iressa® Fact Sheet

2003-12-17

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Contact: BMORS Enquiries

What is IRESSA and what is it used for?

IRESSA is the first drug in a new class of anti-cancer drugs known as epidermal growth factor receptor tyrosine kinase (EGFR-TK) inhibitors.

IRESSA has been specifically developed to fight cancer by targeting an enzyme (TK) involved in cancer cell growth.

IRESSA is used for the treatment of non-small cell lung cancer (NSCLC) in patients having failed two or more different chemotherapy regimens.

NSCLC is one type of lung cancer.

"Health Canada has approved IRESSA with conditions, under the Notice of Compliance with Conditions policy. This authorization reflects the promising nature of the clinical evidence, which must be verified with further studies. Products approved under Health Canada's NOC/c policy, have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment." Approval was based on the efficacy of IRESSA as evidenced by objective responses in patients with locally advanced or metastatic non-small cell lung cancer.

What is non-small cell lung cancer (NSCLC)?

There are over a dozen types of lung cancer that differ in the type of cells found in the tumour. Non-small cell lung cancer accounts for about 80-85% of all cases of lung cancer.

What are the symptoms of lung cancer?

Symptoms of lung cancer include:

• Persistent cough or coughing up blood
• Unusual or unexplained fatigue
• Shortness of breath
• Hoarseness
• Persistent chest, shoulder, or back pain
• Loss of appetite or loss of weight
• Trouble swallowing

Symptoms do not always appear in the early stages of lung cancer. Moreover, having the above signs and symptoms does not necessarily mean you have lung cancer. If you have any of these symptoms, it is best to talk to your doctor.

How is lung cancer diagnosed?

An abnormal chest x-ray could be a sign of lung cancer. Lung cancer may also be suspected if the above symptoms are present. However to confirm a diagnosis of lung cancer, the following special tests may be necessary:

• Imaging studies such as CT scans and MRI's
• Sputum tests
• Lung function tests
• Biopsy
• Blood tests

How does IRESSA work?

• IRESSA works by blocking one of the growth factors (epidermal growth factor, EGF) involved in tumour growth.
• IRESSA blocks the activation of the TK enzyme, which effectively switches off the growth signal within the cell.

What other treatments have been used to treat NSCLC?

This section is intended to provide you with some information on the treatment of lung cancer. It obviously cannot cover all the aspects of lung cancer treatment; you should speak to your doctor if you have any particular questions or concerns.

There are limited treatment options for NSCLC after failure of two or more different chemotherapy regimens. The treatment that will be offered will be determined based on a patient's general health and may include therapy with IRESSA, radiotherapy, or best supportive care (management of pain, shortness of breath etc.).

What are the advantages of IRESSA over other therapies?

IRESSA is a tablet taken once daily.

Beyond its promising efficacy, IRESSA has a novel, targeted way of attacking cancer cells, which is different from traditional chemotherapies. IRESSA is exempt from common chemotherapy side effects such as neutropenia (decrease of infection fighting cells in the blood, which causes susceptibility to life-threatening infections), or other blood-related toxicities.

What are the side effects and how serious are they?

The anti-tumour activity of IRESSA in patients with advanced non-small cell lung cancer is achieved with fewer side effects than seen with chemotherapy. IRESSA is generally well tolerated, with the most common adverse events being mild skin reactions (such as rash or dry skin), and effects on the digestive system (such as diarrhoea, nausea and vomiting). In trials, these adverse events generally occurred within the first month of therapy and were usually mild.

Inflammation of the lungs also known as Interstitial Lung Disease (ILD), has been observed in patients receiving IRESSA at an overall incidence of about 1%, and some cases have been fatal.

In Canada, the current incidence rate of ILD in patients taking IRESSA in clinical trials is 0.18%. It is important to recognize that the incidence of ILD in patients treated with IRESSA is less than with those treated with other commonly used lung cancer therapies, including chemotherapy (approximately 5%) and radiation (approximately 11%). The most common cause of ILD in progressive NSCLC is previous radiotherapy.

Haemorrhage is a potentially severe adverse event that has been reported at an incidence of 0.7% (7 of every 1000 patients) in patients taking IRESSA. Patients with tarry dark stool, blood in stool, urine, or sputum, or sudden, severe headache should seek medical attention immediately.

Some patients have suffered from ulcer on the surface of the eye (cornea), sometimes with in-growing eyelashes. Patients should contact their physician if they experience any new eye problems, such as pain, redness or change in vision.

What do patients need to know about using IRESSA?

If a patient experiences serious breathlessness, or a sudden worsening breathlessness, possibly with a cough or fever, they should inform their doctor as soon as possible and should be closely monitored. Because IRESSA may interact with many other medications, including over-the-counter medications (those that can be obtained without a prescription), as well as natural health products, patients should inform their doctors about all medications they are taking. Patients should also inform their physicians of previous (investigated or uninvestigated) history of fainting spells.

Patients with tarry dark stool, blood in stool, urine, or sputum, or sudden, severe headache should seek medical attention immediately.

Who can be treated with IRESSA?

IRESSA has been approved for the treatment of patients with advanced non-small cell lung cancer after failure of two or more prior chemotherapy regimens.

How is IRESSA available?

IRESSA is available as a tablet, which contains 250 mg of gefitinib.
IRESSA comes in blister packs containing 30 tablets.

How is IRESSA taken?

Take one 250 mg tablet, once a day, at about the same time every day, with or without food. Higher doses do not produce a better response and lead to increased severity of side effects.

Treatment should continue as long as the patient continues to benefit.

IRESSA should be administered under the supervision of a medical oncologist experienced in the treatment of non small cell lung cancer.

What if a patient forgets to take a dose?

The last dose should be taken as soon as remembered, as long as it is at least 12 hours before the next dose is due. If it is less than 12 hours to the next dose, the patient should not take the dose that was missed.

Can IRESSA be taken with other drugs?

IRESSA may interact with other drugs. In some cases, IRESSA blood levels may be increased or decreased by other drugs. This may increase side effects or decrease effectiveness. Because of these potential drug-drug interactions the patient must discuss all of their medications with their doctor or pharmacist.

Where can I learn more about IRESSA?

http://www.iressa.com
Contact the AstraZeneca Medical Information Department at 1-800-668-6000