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FDA Approves Olaparib for HRR-Mutant mCRPC

Jason M. Broderick @jasoncology
Published: Tuesday, May 19, 2020

The FDA has approved olaparib (Lynparza) for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide (Xtandi) or abiraterone acetate (Zytiga).


There were 2 cohorts in the study. In cohort A, patients had alterations in BRCA1/2 or ATM (n = 245), which are more established markers of HRR. In cohort B (n = 142), patients had an alteration in BARD1, BRIP1, CDK12, CHEK1/2, FANCL, PALB2, PPP2R2A, RAD51B/C/D, or RAD54L, which are all associated with HRR but not as established as those in cohort A. Within each cohort, patients were randomized 2:1 to olaparib or physician's choice of abiraterone plus prednisone or enzalutamide.

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