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AstraZeneca : Lynparza Recommended For Approval In EU For High-risk Early Breast Cancer

AstraZeneca Plc. (AZN.L,AZN) and Merck & Co Inc.'s (MRK) Lynparza or olaparib has been recommended for marketing authorization in the European Union as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations who have HER2-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the OlympiA Phase III trial.

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, new cancers, or death by 42% versus placebo.

Lynparza also demonstrated a statistically significant and clinically meaningful improvement in overall survival, reducing the risk of death by 32% versus placebo. The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials.

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