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# Priority Review for Lynparza sNDA in Ovarian Cancer
- URL: https://www.fdaweb.com/priority-review-for-lynparza-snda-in-ovarian-cancer/
- Published: 2018-11-12T12:00:00.000Z
- Updated: 2026-09-15T00:43:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142795

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](http://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.astrazeneca-us.com%2Fcontent%2Faz-us%2Fmedia%2Fpress-releases%2F2018%2Fsolo-1-phase-iii-trial-demonstrates-lynparza-maintenance-therapy-cut-the-risk-of-disease-progression-or-death-by-70-in-patients-with-newly-diagnosed-advanced-brca-mutated-ovarian-cancer-10212018.html&esheet=51898142&newsitemid=20181112005163&lan=en-US&anchor=pivotal+Phase+III+SOLO-1+trial&index=1&md5=e14f5831c853ccbc240ab1a1842b13a0&ref=fdaweb.com). 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.