Therapy Areas: Oncology
Lynparza Approved in the EU as Adjuvant Treatment for Patients with Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer
8 August 2022 - - The European Commission has approved Lynparza as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm), who have human epidermal growth factor receptor 2 -negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy, British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca (LSE: AZN) (STO: AZN) (NASDAQ: AZN) AstraZeneca and US-based pharmaceutical company Merck (NYSE: MRK) said.

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