AstraZeneca Canada's IRESSA receives approval for treatment of NSCLC

With a recent Health Canada approval for IRESSA(R), Canadian lung cancer patients can now be tested for EGFR mutation status and be treated with a more effective and better tolerated alternative to chemotherapy, as a first-line therapy

AstraZeneca Canada announces the recently approved indication for IRESSA(R), a once-daily oral targeted therapy 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). In conjunction with this approval, AstraZeneca is also announcing the availability of a diagnostic test which can now determine a patient's EGFR mutation status, representing a new era in personalized lung cancer treatment in Canada.

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

"IRESSA, in conjunction with EGFR mutation testing, represents an important step forward in the treatment of this devastating disease," said Dr. Glenwood Goss, Head, Medical Oncology, Ottawa Hospital Cancer Centre. "For the first time, Canadian patients with EGFR mutation-positive advanced NSCLC will have a more effective and better tolerated first-line treatment alternative to chemotherapy, bringing clarity and peace of mind."

Through genetic testing, physicians can now identify which of the distinct EGFR gene mutations their patients have (mutation-positive or mutation-negative) and determine the most appropriate first-line therapy. This shift to a personalized care model allows oncologists to select treatments according to who will benefit. This model will ultimately reduce the risk of progression and positively impact quality of life and symptom control for specific lung cancer patients.

AstraZeneca Assists with EGFR Testing for Canadians

AstraZeneca Canada will fund testing and drug access through the IRESSA Alliance Program established to assist eligible patients. This program will be available on an introductory basis prior to public and private coverage. AstraZeneca is currently developing a website on EGFR mutation status for physicians and patients with lung cancer, as well as a site to support patients on IRESSA. All newly diagnosed NSCLC patients should speak with their physician about testing to understand their options for mutation status testing.

"Understanding how lung cancer is treated can be confusing for patients when they are first diagnosed," said Catherine Black of Lung Cancer Canada. "But now, with this targeted approach to lung cancer care, patients in partnership with their physician, can have confidence that they are selecting the right treatment based on their particular tumour type."

"To be diagnosed with lung cancer is terrifying," said Roz Brodsky. "As a five year survivor, I am thrilled that we now have more tools available that will ensure people get the right treatment for their particular type of lung cancer. Targeted therapies like IRESSA offer new hope to so many in their fight against lung cancer."