> ## 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.

# Clovis NDA for Rubraca Gets Accelerated Approval
- URL: https://www.fdaweb.com/clovis-nda-for-rubraca-gets-accelerated-approval/
- Published: 2020-05-18T12:00:00.000Z
- Updated: 2026-09-14T16:15:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146808

FDA has granted accelerated approval for a Clovis Oncology NDA for Rubraca (rucaparib) for patients with deleterious BRCA-mutated (germline or somatic) metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor-directed therapy and a taxane-based chemotherapy. Approval was based on data from an ongoing, multi-center, single arm clinical trial in 115 patients. Data showed that the objective response rate was 44% and the duration of response was 1.7 to 24-plus months, an FDA release says. Fifteen of the 27 (56%) patients with confirmed objective responses had a DOR greater than six months.