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# FDA Priority Review for Lynparza sNDA for Breast Cancer
- URL: https://www.fdaweb.com/fda-priority-review-for-lynparza-snda-for-breast-cancer/
- Published: 2017-10-18T12:00:00.000Z
- Updated: 2026-09-14T22:56:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139905

FDA has accepted for priority review an AstraZeneca supplemental NDA for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings. The submission is based on the positive results from the [Phase III OlympiAD trial](https://www.astrazeneca.com/media-centre/press-releases/2017/lynparza-significantly-reduces-the-risk-of-disease-worsening-or-death-in-patients-with-BRCA-mutated-metastatic-breast-cancer-04062017.html?ref=fdaweb.com) published in the [*New England Journal of Medicine*](http://www.nejm.org/doi/full/10.1056/NEJMoa1706450?ref=fdaweb.com). The agency has set a user fee review action target date for the first quarter of 2018.

AstraZeneca says this is the first submission for a poly ADP-ribose polymerase (PARP) inhibitor outside ovarian cancer and the third indication submission for Lynparza in the U.S. The therapy was first approved 12/2014 as a capsule formulation, making it the first PARP inhibitor to be approved. It is currently being tested in a range of tumor types including breast, prostate and pancreatic cancers, the company says.