16 November 2018 - - The US Food and Drug Administration has accepted a supplemental New Drug Application and granted priority review for the approval of Lynparza (olaparib) (two 150 mg tablets twice daily) as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer who were in complete or partial response following 1st-line standard platinum-based chemotherapy, Anglo-Swiss drugmaker AstraZeneca and US-based Merck and Co., Inc. said.

A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2019.

This is the first regulatory submission acceptance for a poly ADP-ribose polymerase inhibitor in the advanced ovarian cancer 1st-line maintenance setting, and if approved will be the fourth indication for Lynparza in the US.

This submission was based on positive results from the pivotal Phase III SOLO-1 trial. The trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival for Lynparza compared to placebo, reducing the risk of disease progression or death by 70% in patients with newly-diagnosed, BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy (HR 0.30 [95% CI 0.23-0.41], p