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# AstraZeneca, Merck sNDA for Lynparza
- URL: https://www.fdaweb.com/astrazeneca-merck-snda-for-lynparza/
- Published: 2021-11-30T12:00:00.000Z
- Updated: 2026-09-14T17:23:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150669

FDA has accepted for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) for the adjuvant treatment of patients with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. The agency has set a user fee review action target date during the first quarter of next year.

The submission is based on data from the Phase 3 OlympiA trial that showed Lynparza demonstrated a “statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrence, second cancers or death by 42% versus placebo,” the companies say.

Lynparza is approved in the U.S., EU, Japan and several other countries for treating patients with germline BRCA-mutated, HER2-negative metastatic breast cancer previously treated with chemotherapy and, if hormone receptor-positive, endocrine therapy if appropriate.