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FDA Grants Priority Review to Olaparib for HRR-Mutant mCRPC

Gina Columbus @ginacolumbusonc
Published: Monday, Jan 20, 2020

The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for olaparib (Lynparza) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have deleterious or suspected deleterious or somatic homologous recombination repair (HRR) gene mutations, and who have also progressed on prior therapy with a new hormonal agent.1

The designation is based on findings from the phase III PROfound trial, which were presented during the 2019 ESMO Congress. In the study, olaparib led to a 66% reduction in the risk of disease progression or death (HR, 0.34; 95% CI, 0.25-0.47; P <.0001) compared with abiraterone acetate (Zytiga) or enzalutamide (Xtandi) in patients with BRCA1/2- or ATM-mutant mCRPC.2,3

Overall, the trial showed that olaparib demonstrated a 51% reduction in the risk of disease progression or death versus either of the antiandrogen agents (HR, 0.49; 95% CI, 0.38-0.63; P <.0001) in the entire population of patients with HRR-mutant mCRPC who had mutations in genes for BRCA1/2, ATM, CDK12, or 11 other HRR-mutated genes.

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