Lynparza® (olaparib) tablets receive approval as maintenance therapy treatment for ovarian cancer regardless of BRCA status

The treatment demonstrates a 65 per cent reduction in disease progression or deathⁱ

MISSISSAUGA, ON, May 8, 2018 /CNW/ - AstraZeneca today announced Health Canada's approval for Lynparza^® (olaparib) tablets, as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed (PSR), high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.ⁱⁱ Marketing authorization with conditions has been granted for treatment of patients with BRCA wild type status, pending the results of trials to verify its clinical benefit. The indication also coincides with the approval of a new tablet formulation of Lynparza, which reduces daily pill intake from 16 capsules to four tablets daily.ⁱⁱⁱ

"This new indication will have a huge impact on women living with high-grade ovarian cancer – a population that has seen limited treatment advances over the past few decades," said Dr. Amit Oza, Head, Division of Medical Oncology and Hematology at Princess Margaret Cancer Centre, University Health Network, and Professor of Medicine, University of Toronto. "While it is still important for women to know their BRCA status, more women with this disease, regardless of a BRCA mutation, will now have access to the significant clinical benefits of maintenance treatment that can control their disease for a longer period of time."

Two randomized trials supported the new approval:

• SOLO-2 (n=295) confirmed the benefit of Lynparza in germline BRCA-mutated patients, demonstrating a 70 per cent reduced risk of disease progression or death (HR 0.30 [95% CI, 0.22-0.41], P<0.0001) and improved median progression-free survival (PFS) to 19.1 vs 5.5 months for placebo by investigator-assessed analysis.^iv
• Study 19 (n=265) showed that Lynparza in patients regardless of BRCA status reduced the risk of disease progression or death by 65 per cent and improved median PFS to 8.4 vs 4.8 compared with placebo by investigator-assessed analysis (HR 0.35 [95% CI, 0.25-0.49], P<0.00001).^v The study also showed that Lynparza reduced the risk of disease progression or death by 46 per cent and improved median PFS to 7.4 vs 5.5 compared with placebo in BRCA wild type patients (HR 0.54 [95% CI, 0.34-0.85], P=0.00745).^vi

Ovarian cancer is the most fatal women's cancer in Canada.^vii The majority of cases are high-grade epithelial ovarian cancer. Approximately 25 per cent of Canadian women with this type of ovarian cancer have an abnormality in their BRCA genes, and 75 per cent are wild type (non-mutated).^viii  

"For women with ovarian cancer, few treatments have become publicly available for many years. Our community has been vocal in pressing government and manufacturers alike to work together in making urgently needed treatments available to benefit women with this disease," said Elisabeth Baugh, CEO of Ovarian Cancer Canada. "This approval is good news, albeit an early step, along the way to opening up treatment options for a broader group of women with ovarian cancer, regardless of their BRCA status. It helps support our ongoing quest to ensure all women with this disease can live fuller, better and longer lives."

About Lynparza (olaparib)
Lynparza was the first Health Canada-approved oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR) pathway deficiencies to potentially kill cancer cells. ^ix It is the first PARP inhibitor to be approved as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer regardless of BRCA status. Health Canada first issued a Notice of Compliance with Conditions for Lynparza capsules in April 2016, which followed the announcement of the approval of Lynparza by the FDA and the European Union in December 2014. In May 2018, Health Canada granted approval for the new tablet formulation of Lynparza for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. For treatment of patients with BRCA wild type status, marketing authorization with conditions was granted, pending the results of trials to verify its clinical benefit. 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 Ovarian Cancer
Ovarian cancer is the most fatal women's cancer in Canada. Every day, five Canadian women will die from this disease. ^x Ovarian cancer is difficult to detect and often misdiagnosed, and since it is often caught in later stages, 56 per cent of women diagnosed with ovarian cancer will die within five years.^xi

The risk of developing ovarian cancer is increased in women with specific inherited genetic abnormalities, including BRCA mutations. Up to 60 per cent of women with a BRCA mutation will be diagnosed with ovarian cancer.^xii

With genetic testing, women who carry the BRCA gene can determine whether increased observation and preventive action (e.g. removal of the fallopian tubes and/or ovaries) are viable options. Women already diagnosed with BRCA-mutated or high-grade ovarian cancer should speak to their doctor about new treatment options available to them.

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 headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at www.astrazeneca.ca.

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ⁱ AstraZeneca Canada Inc., Lynparza^® (olaparib) tablet Product Monograph. May 2018

ⁱⁱ Ibid.

ⁱⁱⁱ Ibid.

^iv Ibid.

^v Ibid.

^vi Ibid.

^vii Ovarian Cancer Canada. About Ovarian Cancer. Accessed April 11, 2018. Available at: http://www.ovariancanada.org/about-ovarian-cancer

^viii Ovarian Cancer Canada. About Ovarian Cancer. Disease Basics. Accessed April 18, 2018. Available at: http://ovariancanada.org/About-Ovarian-Cancer/Disease-Basics/What-is-ovarian-cancer 

^ix AstraZeneca Canada Inc., Health Canada approves Lynparza™ for the Treatment of Ovarian Cancer in Patients with BRCA-Mutations. Newswire.ca. May 2016. Accessed April 11, 2018. https://www.newswire.ca/news-releases/health-canada-approves-lynparza-for-the-treatment-of-ovarian-cancer-in-patients-with-brca-mutations-577929961.html

^x Ovarian Cancer Canada. About Ovarian Cancer. Accessed April 11, 2018. Available at: http://www.ovariancanada.org/about-ovarian-cancer

^xi Ovarian cancer: Survival statistics. Accessed April 11, 2018 Available at: http://www.statcan.gc.ca/pub/82-624-x/2015001/article/14212-eng.htm#a1

^xii Ovarian Cancer Canada. Hereditary One-Pager. Page 2. On file.

SOURCE AstraZeneca Canada Inc.

Stacey Brown, Senior Manager, Corporate Communications, AstraZeneca Canada, Tel: [phone] ext. 45733, Email: [e-mail]; Hibaq Ali, Weber Shandwick Canada, Tel: [phone], Email: [e-mail]