AstraZeneca Canada recently announced that Lynparza (olaparib), a first-of-its-kind treatment for BRCA-mutated ovarian cancer, recently received a positive clinical recommendation for reimbursement by the pan-Canadian Oncology Drug Review (pCODR) panel. This regulatory action is an important first step toward providing Canadian women with access to the treatment.
“This is a great step forward for Canadian women living with BRCA-mutated ovarian cancer,” Karen Heim, vice president of patient access and established brands at AstraZeneca Canada, said in a press release. “Treatment options are limited and each day, five Canadian women die from ovarian cancer. 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.”
The decision reflects the robust clinical evidence that supports the benefits of Lynparza for use in a well-defined subset of ovarian cancer patients, AstraZeneca says.
Approximately 15% of all ovarian cancer cases are due to hereditary conditions, mostly a BRCA gene mutation. Lynparza was developed as a maintenance treatment for patients with platinum-sensitive relapsed BRCA-mutated ovarian cancer.
Recently published clinical data show that among patients whose tumors responded to platinum-based chemotherapy, Lynparza significantly reduced the risk of disease progression by 70%, with patients taking a median of 19.1 months to see their disease progress, compared with 5.5 months among patients receiving a placebo.
Lynparza was approved by Health Canada in April 2016 and first entered pCODR review in March 2016. 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 AstraZenaca’s Oncology Patient Support program.
Since 2014, over 45 countries have approved Lynparza. In many of them, such as the U.K., Australia, and some Scandinavian countries, Lynparza is publicly reimbursed. Health Canada’s notice of compliance with conditions for Lynparza followed the announcement of Lynparza approval by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in December 2014.
“There is a tremendous need for treatments that provide both progression-free survival and improved quality of life,” said Amit Oza, head of the medical oncology and hematology division at Princess Margaret Cancer Center in 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.”
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