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# FDA Priority Review for Clovis Ovarian Cancer Therapy
- URL: https://www.fdaweb.com/fda-priority-review-for-clovis-ovarian-cancer-therapy/
- Published: 2016-08-23T12:00:00.000Z
- Updated: 2026-09-14T21:26:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136587

FDA has accepted for priority review a Clovis Oncology NDA seeking accelerated approval for rucaparib and its use in treating advanced ovarian cancer in patients with deleterious BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations (as detected by an FDA-approved test) and who have been treated with two or more chemotherapies. The user fee review target date is 2/23/2017.

The submission is supported by data from 106 patients from two multicenter, single-arm, open-label clinical trials. All 106 patients received the starting dose of rucaparib 600 mg twice daily. The major efficacy outcome measure of both trials was objective response rate and duration of response as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria. All responses were confirmed, the company says.