Rubraca Granted FDA Priority Review for Advanced Prostate Cancer with BRCA Mutations

Rubraca Granted FDA Priority Review for Advanced Prostate Cancer with BRCA Mutations
The U.S. Food and Drug Administration (FDA) has granted priority review to Clovis Oncology’s application seeking approval of Rubraca (rucaparib) for treating men with recurrent metastatic castration-resistant prostate cancer (mCRPC) and BRCA mutations. The priority review status will shorten Rubraca’s regulatory review for this indication to six months from the standard 10 months. Clovis submitted the application to the FDA in November 2019, and the agency has set a Prescription Drug User Fee Act action date for May 15 this year, meaning that a decision is due by then. “We are encouraged by the FDA’s decision to grant priority review to the Rubraca application, which focuses on eligible patients with advanced prostate cancer, for whom new treatment options are very much needed,” Patrick J. Mahaffy, Clovis Oncology’s president and CEO, said in a press release. Ne
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