Posted by Michael Wonder on 12 Nov 2018
US FDA accepts regulatory submission for Lynparza maintenance therapy in newly-diagnosed, BRCA mutated advanced ovarian cancer and grants priority review
12 November 2018 - First US regulatory submission acceptance for a PARP inhibitor as a first-line maintenance treatment for advanced ovarian cancer
AstraZeneca and Merck today announced that the US FDA has accepted a supplemental new drug application for priority review for the use of Lynparza (olaparib) tablets as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy. A Prescription Drug User Fee Act date is set for the first quarter of 2019.
This is the first US regulatory submission acceptance for a poly ADP-ribose polymerase (PARP) inhibitor in the first-line maintenance setting for advanced ovarian cancer, and if approved will be the fourth indication for Lynparza in the US.
