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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. ....

United States , Chana Weinstock , Ashley Rosko , Division Of Oncology , Oncologic Drugs Advisory Committee , University Of Colorado Cancer Center , Office Of Oncologic Diseases , Gi Medical Oncology Program , Ohio State University Comprehensive Cancer Center , Drugs Advisory Committee , Christopher Lieu , Oncology Program , Colorado Cancer Center , Oncologic Diseases , Oncologic Drugs Advisory Committee , Prostate Cancer , Castration Resistant Prostate Cancer , Abiraterone Acetate ,