AstraZeneca and MSD‘s Lynparza (olaparib) has been approved by the European Commission for the treatment of germline BRCA-mutated HER2-negative metastatic breast cancer.

The approval makes it the first PARP inhibitor approved in Europe for patients with this difficult-to-treat disease, and the third EU approval for Lynparza.

The approval was based on data from the randomised, open-label, Phase III OlympiAD trial which assessed Lynparza against the physician’s choice of chemotherapy and found that the drug provided progression-free survival improvement of 2.8 months, and an objective response rate of 52%, which was double that in the chemotherapy arm of the trial.

The risk of disease progression or death was also reduced by 42% versus chemotherapy.

The indication is for patients who should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless they were unsuitable for these treatments.

Dave Fredrickson, executive vice president, Oncology, said: “With this approval, Lynparza provides patients throughout the EU with a targeted and oral chemotherapy-free treatment option for a difficult-to-treat cancer. It also reinforces the importance of testing for biomarkers including BRCA, hormone receptor and HER2 expression, helping physicians to make the most informed treatment decisions for patients.”

Metastatic breast cancer refers to Stage III and IV breast cancer, in which cancer cells have spread beyond the initial tumour site to other organs of the body outside the breast. Since there is no cure for the disease, the goal of current treatment is to delay disease worsening or death.