FDA Approval Summary: Olaparib in Combination With Abiraterone for Treatment of Patients With BRCA -Mutated Metastatic Castration-Resistant Prostate Cancer.
Jaleh FallahJianjin XuChana WeinstockMichael H BraveErik W BloomquistMallorie H FieroTimothy SchaeferAnand PathakAbdelrahmman AbukhdeirVishal BhatnagarHaw-Jyh ChiuTiffany RicksChristy JohnSalaheldin HamedChristal LeeWilliam F PierceShyam KalavarReena PhilipShenghui TangLaleh Amiri-KordestaniRichard PazdurPaul G KluetzDaniel SuzmanPublished in: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2023)
m, the FDA determined that the modest rPFS improvement, combined with clinically significant toxicities, did not demonstrate a favorable risk/benefit assessment.