The CHMP based its positive opinion on results from the Phase 3 OlympiA trial presented during the 2021 American Society of Clinical Oncology annual meeting and published in The New England Journal of Medicine in June 2021.
Breast cancer is the most commonly diagnosed cancer worldwide, with an estimated 2.3m patients diagnosed in 2020.
In the European Union, one in seven people who were assigned female at birth will develop breast cancer in their lifetime.
Approximately 75% of breast cancer patients worldwide are diagnosed with early breast cancer; however, a quarter of these patients will experience disease recurrence following surgery. In Europe, germline BRCA mutations are found in approximately 9% of patients.
In the trial, Lynparza demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, second cancers or death by 42% (HR=0.58 [99.5% CI, 0.41-0.82]; p
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