FDA Priority Review for Lynparza sNDA for Breast Cancer

FDA has accepted for priority review an AstraZeneca supplemental NDA for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings. The submission is based on the positive results from the Phase III OlympiAD trial published in the New England Journal of Medicine. The agency has set a user fee review action target date for the first quarter of 2018.

AstraZeneca says this is the first submission for a poly ADP-ribose polymerase (PARP) inhibitor outside ovarian cancer and the third indication submission for Lynparza in the U.S. The therapy was first approved 12/2014 as a capsule formulation, making it the first PARP inhibitor to be approved. It is currently being tested in a range of tumor types including breast, prostate and pancreatic cancers, the company says.