Health Canada Endorsed Important Safety and Efficacy Information on

							           Health Canada Endorsed Important Safety and Efficacy Information on

                           IRESSA® (gefitinib) 250 mg Tablets



June 5, 2006

Subject:        Health Canada further restricts the indication of IRESSA® to patients
                currently benefiting from IRESSA treatment and whose tumours are
                EGFR positive or unknown.



Dear Healthcare Professional:

AstraZeneca Canada Inc., in consultation with Health Canada, would like to inform you
of a new restriction to the indication of IRESSA® (gefitinib). IRESSA received a Notice
of Compliance with conditions (NOC/c) on December 17, 2003 for third line therapy of
locally advanced or metastatic non-small cell lung cancer (NSCLC). The approval was
based on the Objective Response Rates from two phase II studies.

The ISEL study was the pivotal phase IV commitment which compared the effect of
IRESSA vs. placebo in advanced NSCLC patients, who were refractory to or intolerant of
their most recent regimen, following one or two prior chemotherapy regimens. Results
showed that IRESSA did not improve survival. However, exploratory analysis of
correlation between EGFR status and efficacy suggests that patients whose tumours are
EGFR positive or unknown could benefit from IRESSA. Furthermore, Health Canada
concluded that survival disadvantage in EGFR negative patients on IRESSA cannot be
ruled out.

The INDICATIONS and CONTRAINDICATIONS section of the Product Monograph
is revised as follows:

NO NEW PATIENTS SHOULD START IRESSA.

IRESSA, as monotherapy, is indicated for patients with locally advanced or
metastatic non-small cell lung cancer after failure of two prior chemotherapy
regimens (platinum-based and docetaxel). This indication is restricted to these lung
cancer patients who are currently benefiting from IRESSA and whose tumours are
EGFR expression status positive or unknown. The efficacy of IRESSA was
originally based on objective responses. A subsequent study failed to demonstrate
improved survival with IRESSA use. IRESSA remains available to benefiting
patients through pharmacies; however, for continued supply of the drug, patients
will have to be registered by a pharmacist into the IRESSA Patient Registry by
contacting 1-866-473-7720.
IRESSA is contraindicated in patients with EGFR expression negative tumours
because survival disadvantage in these patients can not be ruled out. EGFR-
negative expression status was defined as having less than 10% of cells staining for
EGFR using the DAKO EGFR pharmDX kit.

Conditional market authorization is maintained while existing lung cancer patients
continue to benefit from IRESSA.

The local pharmacist will register the patient into the patient registry when the patient
presents to the pharmacy to fill the prescription for IRESSA.

As part of the registration process, pharmacists will provide patients with a copy of the
Public Communication and some additional patient registry information on IRESSA. To
obtain a copy of these documents, please see www.astrazeneca.ca.

In light of the new prescribing information, it is recommended that physicians review
with their patients, the use of IRESSA in their treatment plans, including its benefits and
risks and alternate treatment options, as considered necessary.

Ongoing and new Canadian clinical trials with IRESSA will not be impacted.
AstraZeneca remains committed to continuing IRESSA research and providing new data
to Health Canada as it becomes available.

Any suspected adverse drug reaction can be reported to:
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, ON L4Y 1M4
Tel: 1-800 433-0733
Fax : 1-800-267-5743
www.astrazeneca.ca

Any suspected adverse drug reactions 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 (AR), consumers and Health professional 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:
Therapeutics Products Directorate
Telephone: (613) 941-3171
Fax: (613) 941-1365
E-mail: BMORS_Enquiries@hc-sc.gc.ca
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:

Kazimierz R. Borkowski, Ph.D.
Vice-President Medical Affairs


IRESSA® and the AstraZeneca logo are trade-marks of the AstraZeneca group of companies.