EMA approves Lynparza to treat patients with germline BRCA1/2-mutations (gBRCAm) with HER2-negative metastatic breast cancer

AstraZeneca and MSD Inc. have announced the European Commission has approved Lynparza (olaparib) as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (gBRCAm), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer. Under the licensed indication, patients 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. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.

The approval was based on data from the randomised, open-label, Phase III OlympiAD trial which tested Lynparza vs. physician’s choice of chemotherapy (capecitabine, eribulin, or vinorelbine). In the trial, Lynparza provided patients with a statistically-significant median progression-free survival improvement of 2.8 months (7.0 months for Lynparza vs. 4.2 months for chemotherapy). Patients taking Lynparza experienced an objective response rate (ORR) of 52%, which was double the ORR for those in the chemotherapy arm (23%).

This is the third indication for Lynparza in the EU. Lynparza has a broad clinical development programme, including the ongoing Phase III OlympiA which is testing Lynparza as an adjuvant treatment in patients with gBRCAm HER2-negative breast cancer.