Pan-Canadian Oncology Drug Review Recommendation Supports the Use of Tagrisso® (osimertinib) as the Standard of Care for T790M Mutated Non-Small Cell Lung Cancer

AstraZeneca is committed to rapid and collaborative discussions with pan-Canadian Pharmaceutical Alliance and provinces to get Tagrisso to Canadian patients

MISSISSAUGA, ON, May 8, 2017 /CNW/ - AstraZeneca applauds the pan-Canadian Oncology Drug Review (pCODR) for its overwhelmingly positive clinical recommendation of the reimbursement of Tagrisso® (osimertinib), a novel, targeted treatment for a subset of non-small cell lung cancer (NSCLC) patients.¹ Tagrisso is the first and only oral, targeted therapy shown to shrink tumour size and slow disease progression in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC  who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.²

The positive recommendation was based on the results of the phase III AURA3 trial which showed that Tagrisso offered a statistically-significant and clinically meaningful improvement in progression-free survival versus standard platinum-based doublet chemotherapy (10.1 months vs 4.4 months, hazard ratio [HR] 0.30; 95% confidence interval (CI):0.23, 0.41; p<0.001).³ Based on these trial results, pCODR's recommendation supports the use of Tagrisso as the new standard of care for T790M mutated NSCLC patients who have progressed following EGFR TKI therapy.

"We are very pleased with pCODR's recommendation for the reimbursement of Tagrisso," says Karen Heim, Vice President, Patient Access & Established Brands, AstraZeneca Canada. "Securing a positive pCODR recommendation is a critical first step toward ensuring patients have public access to this new treatment, a medicine proven to provide extended survival for patients. We now urge the pan-Canadian Pharmaceutical Alliance and provinces to work quickly to ensure that patients can gain public access to Tagrisso as soon as possible."

Canadians who receive a lung cancer diagnosis are in desperate need of time. Fewer than 17 per cent of patients diagnosed with NSCLC will live more than five years following diagnosis.⁴ Tagrisso had one of the fastest development programs from start of clinical trials to regulatory approval and into clinical practice, and it is presently approved in 46 countries. Despite being approved by Health Canada under the accelerated approval framework in mid-2016, this important medicine is still not publicly reimbursed in Canada. AstraZeneca is committed to working with the pan-Canadian Pharmaceutical Alliance, provinces and territories to ensure that Tagrisso is made publicly available as soon as possible. For these patients, there is no time to wait.

"The positive recommendation from pCODR underscores the robust clinical benefit I have seen in my own patients and demonstrated in the Tagrisso clinical trials," says Dr. Glenwood Goss, Professor of Medicine, University of Ottawa, and Director of Clinical and Translational Research at the Ottawa Hospital Cancer Centre. "Tagrisso is a much needed new therapy, which will significantly extend the lives of some lung cancer patients allowing them to spend valuable time with their families. Tagrisso has two important characteristics relevant to patients namely, good efficacy against lung cancer with excellent patient tolerance."

About Tagrisso
Tagrisso, approved by Health Canada in July 2016, is the first oral, targeted therapy shown to shrink tumour size and potentially slow disease progression in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC in patients who have progressed on or after EGFR-TKI therapy.⁵ In Canada, Tagrisso was reviewed under Health Canada's accelerated approval framework and has been granted the Notice of Compliance with Conditions (NOC/c), based on promising evidence of clinical efficacy data, pending the results of additional trials to verify its clinical benefit.⁶ In the U.S., Tagrisso was granted Fast Track, Breakthrough Therapy, Priority Review and Accelerated Approval Status by the FDA,⁷ and was granted Accelerated Assessment and Priority Review status in Europe⁸ and Japan.⁹ Tagrisso was recently granted full approval by the FDA and European Commission.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on three important areas of healthcare: Cardiovascular and Metabolic disease; Oncology; and Respiratory, Inflammation and Autoimmunity. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ more than 675 employees across the country and our AstraZeneca Canada headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at www.astrazeneca.ca.

References

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¹ TAGRISSO™ (osimertinib) Product Monograph. Accessed May 4, 2017. Available at: https://www.astrazeneca.ca/content/dam/az-ca/downloads/productinformation/TAGRISSO%20-%20Product-Monograph.pdf. Accessed May 4, 2017.
² Ibid.
³ Mok, T. S., et al. (2017). Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer. New England Journal of Medicine, 376(7), 629-640. doi:10.1056/nejmoa1612674. Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1612674. Accessed May 4, 2017.
⁴ Lung Cancer Canada. 2015 Faces of Lung Cancer Report. Available at: http://www.lungcancercanada.ca/getmedia/7f1ad2f4-2bb0-45e8-9bf5-d4fa01779a68/The-Faces-of-Lung-Cancer-2015.aspx. Accessed on May 4, 2017.
⁵ TAGRISSO™ (osimertinib) Product Monograph. Accessed May 4, 2017. Available at: https://www.astrazeneca.ca/content/dam/az-ca/downloads/productinformation/TAGRISSO%20-%20Product-Monograph.pdf
⁶ Ibid.
⁷ Tagrisso (osimertinib) receives US FDA full approval. Press release issued March 31, 2017. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2017/tagrisso-osimertinib-receives-us-fda-full-approval-31032017.html. Accessed on May 3, 2017
⁸ Tagrisso receives full approval in the EU. Press release issued April 25, 2017. Available at: https://www.astrazeneca.com/media-centre/press-releases/2017/tagrisso-receives-full-approval-in-the-eu-25042017.html. Accessed on May 3, 2017.
⁹ AstraZeneca PLC. TAGRISSO™ (osimertinib) approved in Japan for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer. Press release issued on March 29, 2016. Available at: https://www.astrazeneca.com/media-centre/press-releases/2016/tagrisso-approved-in-japan-for-patients-with-egfr-t790m-mutation-positive-metastatic-non-small-cell-lung-cancer-29032016.html. Accessed on May 3, 2017.

SOURCE AstraZeneca Canada Inc.

Michelle Marchione, Senior Manager, Corporate Communications, AstraZeneca Canada, Tel: [phone], Email: [email protected]

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