FDA Grants Olaparib Priority Review in BRCA+ Breast Cancer

October 18, 2017 – The FDA has granted a priority review to a supplemental New Drug Application (sNDA) for olaparib for the treatment of patients with germline BRCA-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic settings, according to AstraZeneca and Merck, the co-developers of the PARP inhibitor. This application is based on results from the phase III OlympiAD trial, which … (leggi tutto)