Posted by Michael Wonder on 18 Oct 2017
US FDA accepts regulatory submission for Lynparza in metastatic breast cancer and grants priority review
18 October 2017 - Regulatory submission acceptance is first for a PARP inhibitor beyond ovarian cancer.
AstraZeneca and Merck today announced that the US FDA has accepted and granted priority review for a supplemental new drug application for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neo-adjuvant, adjuvant, or metastatic settings. A Prescription Drug User Fee Act date is set for the first quarter of 2018.
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 US. The sNDA is based on the positive results from the Phase III OlympiAD trial published in the New England Journal of Medicine.
