AstraZeneca and Merck’s Lynparza Gets EU Nod for High-Risk Early Breast Cancer

AstraZeneca and Merck’s Lynparza (olaparib) has received approval from the European Commission as a monotherapy or in combination with endocrine therapy as an adjuvant treatment for adults with human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer.

The approval is specifically for patients with germline BRCA1/2 mutations previously treated with neoadjuvant or adjuvant chemotherapy.

The approval was supported by results of a phase 3 clinical trial in which Lynparza demonstrated statistically significant improvements in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, new cancers or death by 42 percent compared with placebo.

Lynparza is a PARP inhibitor that prevents an enzyme from repairing cancer cells. On March 11, the FDA approved the drug for the same indication.