Approval for Lynparza in early breast cancer indication

4 August 2022

Lynparza (olaparib) has been approved in the European Union (EU) as adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

This latest approval for the PARP inhibitor was based on results from the OlympiA Phase III trial, published in The New England Journal of Medicine, and follows the recommendation for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use of Lynparza in this setting.

In the trial, the AstraZeneca (LSE: AZN) and Merck & Co (NYSE: MRK) drug 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% versus placebo.

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