AstraZeneca and Merck announced 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.
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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.
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.