Health Canada grants accelerated approval for Lynparza for the adjuvant treatment of deleterious germline BRCA -mutated (g BRCA m), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer

Patients must have confirmation of agermline BRCA mutation before Lynparza treatment is initiated.

"Although most HER2-negative early breast cancers now have excellent outcomes, the risk of disease recurrence for persons with high-risk breast cancers and BRCA mutations remains unacceptably high, with a significant potential to advance to advanced disease, where a cure is no longer an option," said Dr. Karen Gelmon, Professor of Medicine, University of British Columbia and Medical Oncologist, BC Cancer. "The approval of olaparib is an important step forward, offering these patients a much-needed option that can improve survival for persons with high-risk early breast cancer. It also stresses the importance of BRCA testing as soon as possible after diagnosis to identify eligible patients."

This approval was granted under Health Canada's accelerated review pathway and based on results from the Olympia Phase III trial, presented during the 2021 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine. The Olympia trial demonstrated a reduction in the risk of invasive breast cancer recurrences, second cancers or death by 42 per cent versus placebo (based on a hazard ratio [HR] of 0.58; 95% confidence interval [CI] 0.41-0.82; p<0.0001).