FDA Accepts sNDA for Lynparza for Maintenance Therapy in Advanced Ovarian Cancer and Grants Priority Review

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  • PDUFA date set for 1Q 2019
  • This is the first regulatory submission acceptance for a poly ADP-ribose polymerase (PARP) inhibitor in the advanced ovarian cancer 1st-line maintenance setting


AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) 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. 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 (PARP) 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 (PFS) 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<0.001). With median 41 months of follow-up, the median PFS for patients treated with LYNPARZA (n=260) was not reached compared to 13.8 months for patients treated with placebo (n=131). Of those in the trial receiving LYNPARZA, 60% remained progression-free at 36 months compared to 27% of women in the placebo arm. These data were recently presented for the first time at the European Society for Medical Oncology (ESMO) 2018 Congress and published online in the New England Journal of Medicine.

LYNPARZA is a first-in-class poly ADP-ribose polymerase (PARP) inhibitor approved in the US since 2014. LYNPARZA has a broad clinical-development program and AstraZeneca and Merck are working together to deliver LYNPARZA as quickly as possible to more patients across multiple cancer types, including prostate and pancreatic cancers.