Priority Review for Lynparza sNDA in Ovarian Cancer

FDA has accepted for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) 150 mg tablets twice daily as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated advanced ovarian cancer who are in complete or partial response following first-line standard platinum-based chemotherapy. A user fee review action target is set for the first quarter of 2019.

The companies say this is the first regulatory submission acceptance for a poly ADP-ribose polymerase inhibitor in the advanced ovarian cancer first-line maintenance setting. If approved, this will be the fourth indication for Lynparza in the U.S.

The submission was based on positive results from the pivotal Phase 3 SOLO-1 trial. Data 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 disease, the companies say.