EMA to Review Olaparib in BRCA-mutated, HER2-negative Breast Cancer

April 3, 2018 – The European Medicines Agency has accepted a marketing authorization application for olaparib to treat women with BRCA-mutated, HER2-negative metastatic breast cancer who previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. The submission is based on results from the phase III OlympiAD trial, which showed that the PARP inhibitor olaparib reduced the risk of disease progression or death by 42% and … (leggi tutto)