This approval by the EC was based on results from the Phase 3 OlympiA trial and follows the recommendation for approval of Lynparza in this setting by the European Medicine Agency's Committee for Medicinal Products for Human Use.
The results were published in The New England Journal of Medicine in June 2021.
In OlympiA, Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% (HR=0.58; [99.5% CI, 0.41-0.82]; p
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