FDA approves AZ's Lynparza for breast cancer

FDA approved an sNDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) and partner Merck & Co. Inc. (NYSE:MRK) for ovarian cancer drug Lynparza olaparib 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. The agency said the approval is the first for a PARP inhibitor outside of ovarian cancer, and the first for any drug to treat metastatic breast cancer in patients with germline BRCA mutations.

For the approval, AstraZeneca will receive a $70 million milestone from Merck. Last year, the companies partnered to co-develop and co-commercialize Lynparza worldwide for multiple tumor types (see BioCentury, July 28, 2017)...