FDA Approval Summary: Olaparib in Combination With Abiraterone for Treatment of Patients With <i>BRCA</i>-Mutated Metastatic Castration-Resistant Prostate Cancer

Abstract

In patients with mCRPC, efficacy of the combination of olaparib plus abiraterone was primarily attributed to the treatment effect in the <i>BRCA</i>m subgroup, the indicated population for the approval. For patients without <i>BRCA</i>m, the FDA determined that the modest rPFS improvement, combined with clinically significant toxicities, did not demonstrate a favorable risk/benefit assessment.