Ontario Government Shows Leadership in Oncology by Providing Access to Personalized Treatment

New Ontario Exceptional Access Program will reimburse IRESSA for patients with NSCLC who have activating
mutations of the EGFR-TK

MISSISSAUGA, ON, Nov. 22, 2011 /CNW/ - AstraZeneca Canada congratulates the Ontario government on the recent inclusion of IRESSA (gefitinib) for reimbursement under the Ontario Exceptional Access Program (EAP). This important step means that patients who have locally advanced or metastatic non-small cell lung cancer (NSCLC) and express an EGFR positive mutation will have access to the treatment shown to have a better response for this specific population than standard chemotherapy.

"This major step forward for lung cancer care in Ontario helps bring us up to par with the state of treatment and access around the world," said Dr. Natasha Leighl, Medical Oncologist at the Princess Margaret Hospital.  "Being able to offer patients a treatment targeted to their cancer, with better quality of life and fewer side effects than chemotherapy, has a huge impact on patients and their families."

Through the Ontario EAP, physicians can request patient coverage for IRESSA for first line monotherapy treatment of patients with locally advanced NSCLC and shown to have a confirmed EGFR positive mutation. Patients whose requests are approved will receive 250mg of IRESSA, administered orally once daily, for up to six months at a time, and will be monitored bimonthly to assess disease status and will be discontinued if there is evidence of disease progression.

"Lung cancer is the leading cancer killer of Canadians - more than breast, prostate and colon combined - so it's not surprising that a lung cancer diagnosis can be devastating for a patient," said Hailee Morrison of Lung Cancer Canada. "Having access to a targeted approach to lung cancer care is wonderful news for Ontario lung cancer patients, and we hope that other jurisdictions in Canada will follow the lead of Ontario, as well as British Columbia and Alberta, so that patients have access to the treatment that will best treat their cancer."

EGFR testing can be applied for through www.egfr-canada.ca. Physicians can request patient coverage for IRESSA by completing and faxing the "Request for an Unlisted Drug Product - EAP" form directly to the EAP. The EAP Form can be accessed at http://www.health.gov.on.ca/en/public/forms/odb_fm.aspx. Applications for public reimbursement will be adjudicated by the EAP under its drug coverage criteria.   In particular, EGFR test results must be submitted to the EAP with any application for public coverage of IRESSA.

IRESSA,  a once-daily oral targeted therapy, is an EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor) which targets and blocks the activity of the enzyme that regulates cancer cell proliferation and survival.1 In Canada, IRESSA® is approved for the first-line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of the epidermal growth factor receptor-tyrosine kinase (EGFR-TK).1

IRESSA has a well-established, generally well-tolerated side effect profile and is not typically associated with the cytotoxic side-effects commonly seen with chemotherapy. The most commonly seen side-effects of IRESSA are mild-to-moderate rash and diarrhea.1

In clinical trial, IRESSA had a response rate of over 70 per cent for NSCLC patients who were identified as EGFR mutation positive.2 Approximately 10 per cent of non-Asian NSCLC patients and approximately 40 per cent of Asian NSCLC patients have EGFR mutation-positive  tumours.1 These mutations are more commonly observed in never-smokers, patients with adenocarcinoma histology, females and those of Asian origin.1 Patients with EGFR mutation-negative NSCLC have been shown to respond better to first-line treatment with standard chemotherapy.

About AstraZeneca
AstraZeneca is committed to the research, development and manufacturing of valuable prescription medicines. We have an extensive product portfolio spanning six therapeutic areas: gastrointestinal, cardiovascular, infection, neuroscience, oncology and respiratory. AstraZeneca's Canadian headquarters are located in Mississauga, Ontario, and a state-of-the art drug discovery centre is based in Montreal, Quebec. For more information, please visit the company's website at www.AstraZeneca.ca.


1 IRESSA® Canadian Product Monograph. AstraZeneca Canada. 2009.
2 Mok T et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. New England Journal of Medicine: 361 (10):947-957. 2009.

IRESSA® is a trade-mark of the AstraZeneca group of companies.


SOURCE AstraZeneca Canada Inc.

For further information:

Daniela Cohen
Communications Manager, AstraZeneca Canada
(905) 615-6827
              Elisabeth Mozel-Jury
NATIONAL Public Relations


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