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# Clovis sNDA for Rubraca Accepted for Review
- URL: https://www.fdaweb.com/clovis-snda-for-rubraca-accepted-for-review/
- Published: 2020-01-15T12:00:00.000Z
- Updated: 2026-09-14T15:58:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145850

FDA has accepted for priority review a Clovis Oncology supplemental NDA for Rubraca (rucaparib) and its use as monotherapy treatment in adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer. The agency has set a 5/15 user fee review action target date.

Clovis describes rucaparib as an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers. It is currently FDA-approved as monotherapy for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.