The European Union (EU) has approved AstraZeneca and MSD’s Lynparza (olaparib) 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 (HER2)-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy, AstraZeneca claimed in a statement.
The approval by the European Commission was based on results from the OlympiA phase-III trial published in The New England Journal of Medicine in June 2021 and follows the recommendation for approval in the EU by the Committee for Medicinal Products for Human Use of Lynparza in this setting. 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 per cent versus placebo (based on a hazard ratio [HR] of 0.58; 99.5% confidence interval [CI] 0.41-0.82; p<0.0001), the statement said.
It informed that Lynparza demonstrated a statistically significant and clinically meaningful improvement in Overall Survival (OS), reducing the risk of death by 32 per cent versus placebo (based on a HR of 0.68; 98.5% CI 0.47-0.97; p=0.009). The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials.
In March 2022, Lynparza was approved in the US for the treatment of gBRCAm, HER2-negative high-risk early breast cancer. It is also approved in the US, EU, Japan, and many other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD phase-III trial. In the EU, this indication also includes patients with locally advanced breast cancer, the statement concluded.