Posted by Michael Wonder on 11 Apr 2019
Lynparza approved in EU for the treatment of germline BRCA-mutated HER2-negative advanced breast cancer
10 April 2019 - AstraZeneca and MSD’s Lynparza reduced the risk of disease progression or death by 42% vs. chemotherapy in Phase III OlympiAD trial.
AstraZeneca and MSD today 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.
