FDA Panel Votes Proposed Olaparib/Abiraterone Indication Should Be Restricted to BRCA-Mutant mCRPC
In an 11-to-1 vote, the FDA’s Oncologic Drugs Advisory Committee voted that the proposed indication of olaparib in combination with abiraterone acetate and prednisone or prednisolone for the initial treatment of patients with metastatic castration-resistant prostate cancer should be restricted to those whose tumors harbor a BRCA mutation.