Health Canada Endorsed Important Safety and Efficacy Information on
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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 firstname.lastname@example.org 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.