AZ's Lynparza gets Priority Review for breast cancer

FDA accepted and granted Priority Review to an sNDA for Lynparza olaparib from AstraZeneca plc (LSE:AZN; NYSE:AZN) and partner Merck & Co. Inc. (NYSE:MRK) to treat patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic settings. Its PDUFA date is in 1Q18.

In the Phase III OlympiAD trial for the indication, Lynparza met the primary endpoint of improving progression-free survival (PFS) vs. chemotherapy (see BioCentury, June 9)...