Tagrisso Receives full Health Canada Approval

AstraZeneca Canada announces that Health Canada has granted full approval (Notice of Compliance) for Tagrisso (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. This full approval follows a Notice of Compliance with Conditions for Tagrisso that was granted in July, 2016. The full approval was based on results from the randomized Phase III AURA3 trial demonstrating that Tagrisso is superior to chemotherapy in prolonging progression-free survival (PFS). Tagrisso is the first and only approved medicine indicated for NSCLC patients who have tested positive for the EGFR T790M mutation.

Tagrisso

In the randomized, Phase III AURA3 trial, Tagrisso significantly improved progression-free survival (PFS) versus platinum-based doublet chemotherapy, providing a median PFS of 10.1 months compared to 4.4 months with chemotherapy (hazard ratio 0.30; 70% risk reduction; 95% Confidence Interval [CI]: 0.23; 0.41; P<0.001). The benefit of Tagrisso was reported in patients with or without brain metastases at baseline. Tagrisso's benefit was also consistently demonstrated across all predefined subgroups, including ethnicity, age, gender, smoking history, EGFR mutation subtype (Exon 19 deletion or L858R), and duration of first-line therapy with an EGFR-TKI.

"Non-small cell lung cancer is an aggressive disease, and so timely public reimbursement to medicines that can prolong life is of the utmost importance for patients and their treating physicians," said Dr. Glenwood Goss, Professor of Medicine, University of Ottawa, and Director of Clinical and Translational Research at the Ottawa Hospital Cancer Centre. "This full approval of Tagrisso, founded on data from the AURA3 trial, further underscores the progression-free survival benefit of Tagrisso, including in patients with difficult-to-treat brain metastases, and reinforces the robust clinical benefit I have seen in my own patients. We are hopeful that patients across Canada will soon have public access to this much-needed therapy."

The pan-Canadian Oncology Drug Review granted a positive recommendation for the reimbursement of Tagrisso last year.

On average, 78 Canadians are diagnosed with lung cancer every day and 58 Canadians will die from lung cancer today. More people die of lung cancer than breast cancer, colorectal cancer and prostate cancer combined; deaths from lung cancer represented 26 per cent of all cancer deaths in Canada in 2017. NSCLC is the most common form of lung cancer and accounts for 85 to 90 per cent of all lung cancers in Canada. Often diagnosed in late stage, fewer than 17 per cent of patients with NSCLC will live more than five years following diagnosis. Ethnicity is correlated with an increased risk of certain identifiable genetic mutations in NSCLC. While Caucasians are found to be EGFR mutation-positive in 10-15 per cent of all NSCLC diagnosed, this proportion climbs with an Asian background to around 30-40 per cent of all diagnosed cases.

Tagrisso 80mg once daily tablet is approved in nearly 70 countries around the world, including Canada, and nationally reimbursed in a number of countries including the US, Japan, UK, Italy, Sweden, Israel and South Korea, as the first treatment for patients with locally-advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR TKI therapy. Eligibility for treatment with Tagrisso is dependent on a validated test confirming the presence of the EGFR T790M mutation. In Canada, Tagrisso received a Notice of Compliance with Conditions in July 2016, and full approval (Notice of Compliance) on January 19, 2018.

Tagrsso is an irreversible EGFR inhibitor, pioneered during scientific exploration and engineered to overcome the mechanism of resistance by targeting the T790M resistance mutation. Tagrisso is also being investigated, alone or in combination, in both the adjuvant and metastatic first-line settings, including patients with and without brain metastases, and in those with leptomeningeal disease.

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