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# sNDA for Lynparza Accepted for Review
- URL: https://www.fdaweb.com/snda-for-lynparza-accepted-for-review/
- Published: 2020-01-13T12:00:00.000Z
- Updated: 2026-09-14T15:58:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145832

FDA has accepted for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with bevacizumab (Genentech’s Avastin) for the maintenance treatment of women with advanced ovarian cancer whose disease has shown a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab. The agency has set a user fee review action target date for the second quarter.

The submission is based on the results from the pivotal Phase 3 PAOLA-1 trial, which compared Lynparza when added to standard-of-care bevacizumab versus bevacizumab alone in women with advanced ovarian cancer in the first-line maintenance setting, regardless of their genetic biomarker status or outcome from previous surgery, according to the company. Data showed that Lynparza added to bevacizumab reduced the risk of disease progression or death by 41% and improved progression-free survival to a median of 22.1 months versus 16.6 months for patients treated with bevacizumab alone, it says.

Lynparza is currently approved for treating certain patients with breast, pancreatic and ovarian cancer.