Important Safety Information on IRESSA (gefitinib) - For Health Professionals

Starting date:

September 4, 2007

Posting date:

October 11, 2007

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001625

This is duplicated text of a letter from AstraZeneca Canada Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Iressa (gefitinib)

September 4, 2007

Dear Health Care Professional:

Subject: IRESSA® (gefitinib) 250 mg Tablets: Failure to Demonstrate Non-inferiority in Overall Survival versus Docetaxel. Results from a Japanese Phase III Study in 2nd-line Non-Small Cell Lung Cancer (NSCLC) Patients.

This letter is to inform you, a Health Care Professional involved in the IRESSA Patient Registry (IPR), of the key results from an IRESSA study entitled: A multicentre, randomised, open-label, parallel- group, phase III post-marketing clinical study to compare the overall survival between IRESSA (gefitinib) and docetaxel in patients with advanced or metastatic (Stage IIIB/IV), or recurrent Non-Small Cell Lung Cancer, who failed one or two chemotherapy regimens. This study was conducted in Japan. The following key points were communicated to Health Canada:

• The study failed the primary objective to demonstrate non-inferiority of IRESSA to docetaxel in overall survival: HR 1.12, 95.24% CI 0.89 to 1.40.
• When compared to docetaxel, some secondary endpoints (response rate, time to treatment failure, and quality of life) showed benefit with IRESSA use, but other secondary endpoints did not (progression free survival, disease control rate, and disease-related symptoms).
• No new safety findings were noted.
• There were 3 treatment-related deaths due to interstitial lung disease (ILD) in the IRESSA arm and none in the docetaxel arm.

No patients in Canada should receive IRESSA unless they are enrolled in the IPR. Health Canada, in collaboration with AstraZeneca supports the IPR to allow those patients who were benefiting from IRESSA as of December 31, 2006 to continue in the program as long as they continue to benefit. Please discuss this information with your IPR patients. You may need to reconsider the risk/benefit profile of IRESSA for your patients.

Adverse Event Reporting:

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any occurrence of serious and/or unexpected adverse reactions in patients receiving IRESSA should be reported to AstraZeneca Canada Inc., or Health Canada, at the following addresses:

AstraZeneca Canada Inc.

1004 Middlegate Road

Mississauga, Ontario

L4Y 1M4

Tel: 1-800-433-0733

Fax: 1-800-267-5743

www.astrazeneca.ca

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: 613-957-0337 or Fax: 613-957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free:

Tel: 866-234-2345

Fax: 866-678-6789

cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:

Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS) E-mail: BMORS_Enquiries@hc-sc.gc.ca Tel: (613) 941-3171 Fax: (613) 941-1365

Should you have any questions or require additional information regarding IRESSA^®, please contact AstraZeneca Medical Information at 1-800-668-6000 (English) and/or 1-800-461-3787 (French).

AstraZeneca Canada Inc.

original signed by

Karen Feltmate,

Interim Vice-President, Medical Affairs

IRESSA^® and the AstraZeneca logo are trademarks of the AstraZeneca group of companies.