> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Priority Review for Lynparza sNDA
- URL: https://www.fdaweb.com/fda-priority-review-for-lynparza-snda/
- Published: 2022-08-16T12:00:00.000Z
- Updated: 2026-09-14T17:55:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152521

FDA has accepted for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for treating adult patients with metastatic castration-resistant prostate cancer (mCRPC).

The submission is based on data from the PROpel Phase 3 trial that showed Lynparza in combination with abiraterone reduced the risk of disease progression or death by 34% versus abiraterone alone, according to the company. “The safety and tolerability of *Lynparza* in combination with abiraterone was in line with that observed in prior clinical trials and the known profiles of the individual medicines,” it says.

Lynparza is currently approved for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations) who have progressed following prior treatment with enzalutamide or abiraterone.