Olaparib to treat advanced breast cancer in EU

The European Commission has approved olaparib (Lynparza) as 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.

Patients receiving the therapy 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 olaparib vs. physician’s choice of chemotherapy (capecitabine, eribulin, or vinorelbine). In the trial, olaparib provided patients with a statistically-significant median progression-free survival improvement of 2.8 months.

This is the third indication for olaparib in the EU, said AstraZeneca and MSD.