> ## 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 Approves Tesaro’s Ovarian Cancer Drug
- URL: https://www.fdaweb.com/fda-approves-tesaros-ovarian-cancer-drug/
- Published: 2017-03-27T12:00:00.000Z
- Updated: 2026-09-14T22:13:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138305

FDA has approved a Tesaro, Inc. NDA for Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk in response to platinum-based chemotherapy. Zejula is a poly ADP-ribose polymerase inhibitor that blocks an enzyme involved in repairing damaged DNA. “By blocking this enzyme, DNA inside the cancerous cells may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth,” an agency [release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm548948.htm?ref=fdaweb.com) says.  
  
Approval was based on data from a randomized trial of 553 patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who had received at least two prior treatments of platinum-based chemotherapy and who had experienced a complete or partial response to their most recent chemotherapy treatment. “Patients were tested with an FDA-approved test to determine whether they had a specific gene mutation, called a deleterious or germline BRCA mutation,” the agency says. “The median progression-free survival for patients taking Zejula who had a germline BRCA mutation was 21 months compared to 5.5 months for the same patient population taking a placebo. The median progression-free survival for patients taking Zejula who did not have a germline BRCA mutation was 9.3 months compared to 3.9 months for the same patient population taking a placebo.”