Health Canada approves LYNPARZA™ for the Treatment of Ovarian Cancer in Patients with

First PARP inhibitor offers new treatment approach for the most fatal of women's cancers

MISSISSAUGA, ON, May 3, 2016 /CNW/ - AstraZeneca Canada announced today that Health Canada has approved LYNPARZA™ (olaparib) capsules as a maintenance treatment for patients with platinum-sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer. LYNPARZA is the first poly ADP-ribose polymerase (PARP) inhibitor available in Canada, and has been granted the Health Canada Notice of Compliance with Conditions (NOC/c), based on promising evidence of clinical efficacy and duration of response data.¹

"Health Canada's approval of LYNPARZA is particularly significant for patients with advanced BRCA-mutated ovarian cancer. Until now, there have been very limited options available to this unique segment of women living with this disease," says Dr. Michael Fung Kee Fung, Head, Division of Surgical Oncology, Ottawa Regional Cancer Centre and Professor, Division of Obstetrics & Gynecology and Department of Surgery, University of Ottawa. "The availability of this targeted treatment which works in the presence of BRCA mutations represents a successful application of our growing understanding of this disease. It gives us another way to battle this devastating disease, with fewer side effects compared to existing chemotherapies, which can often be debilitating for patients."

Ovarian cancer is the most fatal women's cancer – every day, five Canadian women will die from this disease.²Difficult to detect and often misdiagnosed, the disease is often caught in its late stages, meaning that 55 per cent of women diagnosed will die within five years.³

A quarter of all ovarian cancer cases are due to hereditary syndromes – up to 60 per cent of women with a BRCA mutation will be diagnosed with ovarian cancer.⁴ A BRCA mutation can be inherited from either parent and women with a BRCA mutation are more likely to be diagnosed with ovarian cancer at a younger age than those without a genetic mutation.⁵ This genetic marker indicates an increased risk, but also now offers the possibility of a targeted treatment option for women already diagnosed with ovarian cancer.⁶

"Outcomes for women living with ovarian cancer haven't significantly improved in over 50 years, the only way to change this is through improved treatments and further research. As more information about the role of genetics in ovarian cancer becomes available, targeted treatments such as LYNPARZA offer new hope for a personalized approach that better treats this disease," says Elisabeth Baugh, CEO, Ovarian Cancer Canada. "It's imperative that women who are diagnosed with ovarian cancer learn about their BRCA status so they can benefit from a treatment regime that is more specific to their particular case."

PARP inhibitors are a new class of targeted cancer therapy that function by disabling the ability of BRCA-mutated tumour cells to repair their damaged DNA. This kills tumour cells, with little or no effect on normal cells.⁷LYNPARZA's approval represents a significant milestone as the first biomarker-driven targeted treatment for BRCA-mutated ovarian cancer, and this innovative and first-of-its-kind treatment has the ability to actively extend progression-free survival.⁸

Patients with relapsed BRCA-mutated ovarian cancer have an incurable and ultimately fatal disease with the prospect of multiple, repeated regimens of cytotoxic chemotherapy with associated cumulative toxicities.⁹ LYNPARZA is generally safe and tolerable, making it suitable as a maintenance therapy, and delays progression and the need for subsequent chemotherapy, offering patients more time before requiring the next chemotherapy.^10,11,12

Regulatory approval is based on efficacy and safety data from a randomized, double-blind, placebo-controlled Phase II study. Efficacy of LYNPARZA is based on an analysis conducted of 136 women with BRCA-mutated advanced ovarian cancer treated with two or more prior lines of chemotherapy. Patients with BRCA-mutated ovarian cancer received the greatest treatment benefit from LYNPARZA, which significantly prolonged median progression-free survival compared with a placebo (11.2 months vs. 4.3 months). Studies have identified most common adverse reactions including mild to moderate nausea, vomiting, fatigue and anaemia.^10,11,12

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.

¹Kaufman B, Shapira-Frommer R, Schmultzler RK et al. Olaparib Monotherapy in Patients With Advanced Cancer and a Germline BRCA1/2 Mutation. Journal of Clinical Oncology 2014. Accessed April 11, 2016. Available at: http://jco.ascopubs.org/content/early/2014/10/30/JCO.2014.56.2728
²Canadian Cancer Society, Statistics Canada, Public Health Agency of Canada, Provincial/Territorial Cancer Registries. Canadian Cancer Statistics 2015. Page 46, Accessed April 11, 2016. Available at: http://www.cancer.ca/en/cancer-information/cancer-101/canadian-cancer-statistics-publication/?region=on
³Ovarian Cancer Canada. Ovarian Cancer Fact Sheet. Accessed April 11, 2016. Available at: http://ovariancanada.org/OCC/media/Content/PDFs/Brochures/Ovarian-Cancer-FactSheet-EN.pdf
⁴Canadian Cancer Society, BRCA gene mutations. Accessed April 11, 2016. Available at: http://www.cancer.ca/en/cancer-information/cancer-101/what-is-a-risk-factor/genetic-risk/brca-gene-mutations/?region=on
⁵Litton, J.K. et al. Earlier age of onset of BRCA mutation-related cancers in subsequent generations. Cancer. 2012 Jan 15;118(2):321-5.
⁶Canadian Cancer Society, BRCA gene mutations. Accessed April 11, 2016. Available at: http://www.cancer.ca/en/cancer-information/cancer-101/what-is-a-risk-factor/genetic-risk/brca-gene-mutations/?region=on
⁷Chen, A, PARP inhibitors: its role in treatment of cancer, Chin J Cancer. 2011 Jul; 30(7): 463–471. Accessed April 11, 2016. Available at: http://www.cjcsysu.com/abstract.asp?idno=17747
⁸LYNPARZA™ (olaparib) Product Monograph, on file.
⁹McWhinney,S, Goldberg, R and McLeod, H, Platinum Neurotoxicity Pharmacogenetics, Molecular Cancer Therapeutics, January 2009 8; 10. Accessed April 11, 2016. Available at: http://mct.aacrjournals.org/content/8/1/10.long
¹⁰LYNPARZA™ (olaparib) Product Monograph, on file.
¹¹Ledermann J, Harter P, Gourley C et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61.
¹²Matulonis U, Oza A, Ho T, Ledermann J et al. Intermediate clinical endpoints: a bridge between progression-free survival and overall survival in ovarian cancer trials. Cancer. 2015 Jun 1;121(11):1737-46.

For further information: Lisa Cancian, Weber Shandwick, Tel: 416-642-7945, E-mail: lcancian@webershandwick.com; Daniela Cohen, AstraZeneca Canada, Tel: 905-615-6827, E-mail: daniela.cohen@astrazeneca.com

Health Canada approves LYNPARZA™ for the Treatment of Ovarian Cancer in Patients with BRCA-Mutations

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