Posted by Michael Wonder on 15 Jan 2020
Clovis Oncology’s Rubraca (rucaparib) granted FDA priority review for advanced prostate cancer
15 January 2020 - FDA has assigned PDUFA date of 15 May 2020.
Clovis Oncology announced today that the U.S. FDA has accepted the company’s supplemental new drug application for Rubraca (rucaparib) and granted priority review status to the application with a Prescription Drug User Fee Act date of May 15, 2020. Clovis submitted the submission for rucaparib as a monotherapy treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer in November 2019.
FDA submission based on data from TRITON clinical program in advanced prostate cancer.
