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. Nearly 12% of men with mCRPC have a mutation in the BRCA1 or BRCA2 genes, which are involved in DNA repair. These tumors rely on other DNA repair mechanisms — including those involving PARP enzymes that act as DNA damage sensors — to survive and grow. Thus, treatments that block PARPs’ activity (PARP inhibitors), such as Rubraca, are particularly effective in BRCA-mutated tumors. Rubraca is already approved for the treatment of several gynecologic tumors carrying BRCA mutations, and as a maintenance therapy regardless of BRCA mutations. Rubraca’s new application was supported by data from the TRITON2 Phase 2 trial (NCT02952534), which is evaluating its safety and effectiveness in up to 360 mCRPC patients with mutations in BRCA genes or in other 13 DNA repair genes known to increase susceptibility to PARP inhibitors. Besides eligible mutations, participants must have
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