AstraZeneca Receives FDA Approval for Lynparza in Adjuvant BRCA-Mutated Breast Cancer

AstraZeneca and Merck today announced that the FDA has approved Lynparza (olaparib) as adjuvant treatment for adults with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. In the Phase 3 OlympiA trial, Lynparza demonstrated a statistically significant improvement in invasive disease-free survival compared to placebo. The 4-year iDFS rate was 82.7% for Lynparza versus 75.4% for placebo. This approval provides patients with BRCA-mutated high-risk early breast cancer a new adjuvant treatment option.