Clovis Oncology’s Rubraca® (rucaparib) Granted FDA Priority Review for Advanced Prostate Cancer
Clovis Oncology, Inc. (CLVS)
Last clovis oncology, inc. earnings: 2/24 04:05 pm
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Source: Business Wire
- Clovis seeks U.S. approval for rucaparib as monotherapy treatment for patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer- FDA submission based on data from TRITON clinical program in advanced prostate cancer- FDA has assigned PDUFA date of May 15, 2020 BOULDER, Colo.--(BUSINESS WIRE)--Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for Rubraca® (rucaparib) and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020. Clovis submitted the sNDA submission for rucaparib as a monotherapy treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer in November 2019.“Recently presented data suggests that Rubraca may play a meaningful role in the treatment of patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant pr
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