New FDA approval for Lynparza

12 March 2022

UK-based AstraZeneca (LSE: AZN) and the USA’s Merck & Co’s (NYSE: MRK) Lynparza (olaparib) on Friday announced that ynparza (olaparib) has been approved in the USA for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. AstraZeneca's shares edged up 1.2% ti 9,385 pence in morning trading today.

The approval by the US Food and Drug Administration was 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.

In the trial, Lynparza demonstrated a statistically-significant and clinically-meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, second cancers or death, by 42% versus placebo (based on a hazard ratio [HR] of 0.58; 95% confidence interval [CI] 0.46-0.74; p<0.0001).

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