First-in-class BRCA-positive Ovarian Cancer Medicine Lynparza® (olaparib) Receives Positive pan-Canadian Oncology Drug Review (pCODR) Recommendation for Provincial Reimbursement

This marks an important first step towards providing Canadian women with access to this treatment

MISSISSAUGA, ON, Sept. 21, 2017 /CNW/ - AstraZeneca Canada is pleased to announce that the pan-Canadian Oncology Drug Review (pCODR) has provided an overwhelmingly positive clinical recommendation for the reimbursement of Lynparza® (olaparib), a first-of-its-kind treatment for BRCA-mutated ovarian cancer.¹ Lynparza is an oral, potent inhibitor of poly (ADP-ribose) polymerase (PARP) available as a maintenance treatment for patients with platinum-sensitive relapsed BRCA-mutated ovarian cancer.² Strong clinical data shows improved progression-free survival (PFS) among patients, as well as significant reduction in disease progression (70%).³

AstraZeneca applauds the decision, noting that this comes as a reflection of the strong clinical evidence that supports the benefits of Lynparza for use in a well-defined subset of ovarian cancer patients.⁴

"This is a great step forward for Canadian women living with BRCA-mutated ovarian cancer," says Karen Heim, Vice President, Patient Access & Established Brands, AstraZeneca Canada. "Treatment options are limited and each day, five Canadian women die from ovarian cancer.⁵ That means every day counts, so we look forward to collaborating and expediting negotiations with the pan-Canadian Pharmaceutical Alliance, provinces and territories to ensure rapid public reimbursement for Lynparza."

Since 2014, more than 45 countries have approved Lynparza. It is also publicly reimbursed in many countries, including the UK, Australia, France, Norway, Denmark and Sweden. Lynparza was approved by Health Canada in April 2016 and first entered pCODR review in March 2016 - the urgent need for access to this novel treatment remains.⁶ In Canada, as a bridge to public reimbursement, AstraZeneca has been providing the treatment to more than 200 eligible, uninsured Canadian patients since 2016 through the AstraZeneca Oncology Patient Support program. 

Ovarian cancer is the most fatal women's reproductive cancer. This year, 2,800 Canadian women will be diagnosed. The disease is difficult to detect and often misdiagnosed, and since it is often caught in later stages, 55 per cent of women diagnosed with ovarian cancer will die within five years.⁷ Approximately 15% of all ovarian cancer cases are due to hereditary syndromes, most due to a BRCA gene mutation.⁸ In fact, up to 60 per cent of women with a BRCA mutation will be diagnosed with the disease,⁸ often at a younger age.⁹

"There is a tremendous need for treatments that provide both progression-free survival and improved quality of life," says Dr. Amit Oza, Head, Division of Medical Oncology and Hematology at Princess Margaret Cancer Centre, University Health Network, and also Professor of Medicine, University of Toronto. "Lynparza represents the first new treatment option for ovarian cancer in 20 years and more importantly, it provides hope for Canadian women with platinum-sensitive relapsed BRCA-mutated ovarian cancer."

About Lynparza® (olaparib)
Lynparza is a first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. It is the first PARP inhibitor to be approved as a maintenance therapy for patients with platinum-sensitive relapsed BRCA-mutated (germline or somatic) ovarian cancer. Health Canada's Notice of Compliance with Conditions for Lynparza follows the announcement of the approval of Lynparza by the FDA on December 19, 2014 and in the European Union on December 18, 2014. AstraZeneca is conducting multiple Lynparza Phase III studies across a variety of indications and tumour types.

Lynparza® is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc.

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 Lynparza^® (olaparib) Product Monograph. Accessed August 30, 2017. Available at: https://www.astrazeneca.ca/content/dam/az-ca/downloads/productinformation/lynparza-product-monograph-en.pdf
² Product Monograph, op. cit.
³ Pujade-Lauraine, J.A., et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017. Accessed August 30, 2017. Available at: http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30469-2/abstract
⁴ Ibid.
⁵ Ovarian Cancer Canada. Hereditary One-Pager. Page 2. Accessed September 27, 2016. On file.
⁶ AstraZeneca Feedback on pERC Initial Recommendation. Lynparza (olaparib) for PSR BRCAm Ovarian Cancer, on file.
⁷ Ovarian cancer: Survival statistics. Accessed August 30, 2017. Available at: http://www.statcan.gc.ca/pub/82-624-x/2015001/article/14212-eng.htm#a1
⁸ Ovarian Cancer Canada. Hereditary One-Pager, op. cit.
⁹ Litton, J.K. et al. Earlier age of onset of BRCA mutation-related cancers in subsequent generations. Cancer. 2012 Jan 15;118(2):321-5.

SOURCE AstraZeneca Canada Inc.

Stacey Brown, Senior Manager, Corporate Communications, AstraZeneca Canada, Tel: [phone], Email: [e-mail]