CHMP positive for Lynparza to treat patients with germline BRCA1/2-mutations who have HER2 negative locally advanced or metastatic breast cancer

AstraZeneca and Merck Inc., announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the use of Lynparza (olaparib) tablets as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable 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 positive opinion is based on data from the randomised, open-label, Phase III OlympiAD trial, which tested Lynparza against the physician’s choice of chemotherapy.