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# FDA Extends Lynparza sNDA Review by 3 Months
- URL: https://www.fdaweb.com/fda-extends-lynparza-snda-review-by-3-months/
- Published: 2022-12-15T12:00:00.000Z
- Updated: 2026-09-14T18:09:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153409

FDA has extended by three months its review of an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) in combination with Janssen’s Zytiga (abiraterone) and prednisone or prednisolone for treating adult patients with metastatic castration-resistant prostate cancer. The companies say the review extension is needed for the full review of the submission. Lynparza is an oral poly ADP ribose polymerase inhibitor currently indicated for treating ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.

The sNDA is based on data from the Phase 3 PROpel trial, and the primary end point was imaging-based progression-free survival (ibPFS) by investigator assessment. In June, the companies reported that median ibPFS was significantly longer in the abiraterone and olaparib arm than in the abiraterone and placebo arm (24.8 vs. 16.6 months).