ZEJULA is approved in Canada for first-line maintenance treatment of women with advanced ovarian cancer

MISSISSAUGA, ON, Oct. 5, 2020 /CNW/ - ZEJULA (niraparib) is now approved in Canada for the monotherapy maintenance treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapyⁱ.

"Tragically, thousands of women will be diagnosed with ovarian cancer in Canada this year, and about 2,000 are expected to die," said Dr. Alex Romanovschi, Country Medical Director, GSK Canada. "ZEJULA represents a significant step forward as GSK is accelerating its oncology pipeline to deliver the next generation of medicines to Canadian patients. As part of GSK's renewed focus on oncology, we're proud that ZEJULA is now approved for first-line maintenance therapy, helping address the needs of Canadians living with these cancers earlier."

Ovarian cancer

Advanced epithelial ovarian cancer is a leading cause of cancer death in women worldwideⁱⁱ. In Canada, it is the 5th most common cancer in women, and the most fatal gynecological cancerⁱⁱⁱ. Ovarian cancer is most frequently diagnosed in women aged 55 to 64 years. It is estimated that this year 3,100 Canadian women will be newly diagnosed with this disease, and 1,950 will die^iv.

Ovarian cancer is often diagnosed at later stages and follows a highly recurrent disease course with a 5-year survival rate of 29% for patients with advanced disease^v. Despite surgical cytoreduction and response to front-line platinum-based chemotherapy, up to 85% of women with advanced ovarian cancer experience cancer disease recurrence, at which point their disease is considered incurable^vi. Maintenance treatments following response to chemotherapy aim to extend the benefit of chemotherapy by delaying time to recurrence and prolonging progression-free survival. As first-line treatment represents a key junction in the management pathway, maintenance therapy in this setting represents an opportunity to improve progression-free survival and maximize cancer remission.

About ZEJULA (niraparib)

ZEJULA is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor. The approval of ZEJULA in the first-line setting was based on the results of the phase III PRIMA study (ENGOT-OV26/GOG-3012), which enrolled patients with newly diagnosed advanced ovarian cancer following a complete or partial response to platinum-based chemotherapy regardless of biomarker status.

In 2019, ZEJULA received approval in Canada for the maintenance treatment of female adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Please consult the Product Monograph at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.

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Trademarks are owned by or licensed to the GSK group of companies.

ⁱ Zejula (niraparib) Canadian Product Monograph, October 2020

ⁱⁱ Global Burden of Disease Cancer Collaboration. Global, regional, and national cancer incidence, mortality, years of life lost, years lived with disability, and disability-adjusted life-years for 32 cancer groups, 1990 to 2015: A systematic analysis for the global burden of disease study. JAMA Oncology. 2016

ⁱⁱⁱ Navaneelan T. 2015. "Trends in the incidence and mortality of female reproductive system cancers." Health at a Glance, Statistics Canada catalogue no. 82-624-X.; Statistics Canada. Ovarian cancer: Survival statistics. 2015. at https://www150.statcan.gc.ca/n1/pub/82-624-x/2015001/article/14212-eng.htm.

^iv Canadian Cancer Society. Ovarian cancer statistics. 2019

^v Torre LA, Trabert B, DeSantis CE, et al. Ovarian cancer statistics, 2018. CA Cancer J Clin 2018;68:284-96;

^vi Foley OW, Rauh-Hain JA, del Carmen MG. Recurrent epithelial ovarian cancer: an update on treatment. Oncology (Williston Park) 2013;27:288-94, 98

SOURCE GlaxoSmithKline Inc.

GSK Enquiries: Corporate Communications [phone] (Mississauga), [phone] (Laval)

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